MESOTHELIOMA CLINICAL TRIAL REVIEW – NINTEDANIB IN TREATING PATIENTS WITH MALIGNANT PLEURAL MESOTHELIOMA THAT IS RECURRENT

Posted on December 6, 2017 by Ellie and Lisa

We encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time- consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov

CLINICAL TRIAL– NCT02568449

Official Title– A Phase II Trial of BIBF 1120 (Nintedanib) in Recurrent Malignant Pleural Mesothelioma

Listing on- www.clinicaltrials.gov

Sponsor- Barbara Ann Karmanos Cancer Institute Wayne State University 4100 John R Detroit, Michigan 48201

Collaborator: National Cancer Institute

Location: 4 total sites- 2 are recruiting 2 not yet recruiting-

University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan, United States 48109 contact Gregory P. Kalemkerian 734 615 4762 kalemker@umich.edu- recruiting
Wayne State University/Karmanos Cancer Institute Detroit Michigan, United States 48201 contact Antoinette J. Wozniak 313 576 8752 wozniakt@karmanos.org -recruiting
University of California Davis Comprehensive Cancer Center Sacramento California, United States 95817 contact David R. Gandara 916 734 8452 david.gandara@ucdmc.ucdavis.edu- not yet recruiting
Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065 contact Marjorie G. Zauderer MD zauderem@mskcc.org – not yet recruiting

Principal Investigator Antoinette J. Wozniak, Barbara Ann Karmanos Cancer Institute Wayne State University 4100 John R Detroit Michigan 48201

Contact– Listed above by site.

Number of Participants– 55 starting date October 2015- estimated completion date January 1, 2018

Purpose- A phase ll trial to study how well Nintedanib works in treating patients with malignant pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria- Adults over age 18 male or female

Inclusion and Exclusion Criteria:

Patients must have histologically confirmed diagnosis of unresectable malignant pleural mesothelioma
Patients must have a Ct scan within 28 days of beginning trial to measure disease- all disease must be assessed by the RECIST criteria.
Patients must have had prior systemically administered platinum-based chemotherapy; pleural space washing with cisplatin does not constitute systemic administration; no more than two prior systemic therapeutic regimens are allowed (including biologics, targeted and immunotherapies), and at least one regimen must have been platinum-based
No prior treatment with BIBF 1120 or any other vascular endothelial growth factor receptor (VEGFR) inhibitor
No known hypersensitivity to BIBF 1120, to its excipients or to contrast media
Patients may have received prior surgery (e.g., pleurectomy, pleurodesis) provided that at least 28 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered
No active brain metastases (e.g. stable for < 4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomization); no leptomeningeal disease
No radiographic evidence of cavitary or necrotic tumors
No centrally located tumors with radiographic evidence (CT or magnetic resonance imaging [MRI]) of local invasion of major blood vessels
Institutions must offer patients the opportunity to submit tissue for future correlative studies
Patients may have received prior radiation therapy provided that at least 14 days have elapsed since the last treatment and patients have recovered from all associated toxicities at the time of registration
Patients must have a Zubrod performance status of 0-1
Absolute neutrophil count (ANC) >= 1,500/mcl
Platelet count >= 100,000/mcl
Serum bilirubin =< institutional upper limit of normal (IULN)
Liver tests- SGOT, AST, SGPT must be less than institution upper limit of normal
Renal tests- less than IULN obtained within 14 days
No proteinuria Common Terminology Criteria For Adverse Events (CTCAE) grade 2 or greater
No therapeutic anticoagulation (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous device) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid < 325mg per day); no history of clinically significant hemorrhagic or thromboembolic event in the past 6 months
Patients must have no evidence of bleeding or coagulopathy; patients must have no pathologic condition other than mesothelioma that carries a high risk of bleeding
No major injuries within the past 10 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
Patients must not have gastrointestinal tract disease resulting in an inability to take oral or enteral medication via a feeding tube or a requirement for intravenously (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
No significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA [New York Heart Association Class] II, serious cardiac arrhythmia, pericardial effusion)
No active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
No active or chronic hepatitis C and/or B infection
Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
No psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule
No active alcohol or drug abuse
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

How the Research Study is Designed to Work-

PRIMARY OBJECTIVES:

To assess the 4-month progression-free survival (PFS) in patients with recurrent, unresectable malignant pleural mesothelioma (MAM) treated with Nintedanib.

SECONDARY OBJECTIVES:

To assess response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in the subset of patients with measurable disease by both RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria and Modified RECIST criteria for pleural tumors.
To assess overall survival.

III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.

To collect tissue samples for future correlative studies related to overall study objectives.

With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.

Please do not hesitate to contact us with any questions.

MESOTHELIOMA CLINICAL TRIAL REVIEW – NINTEDANIB

Posted on December 6, 2017 by Ellie and Lisa

We encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known nationally the statistic for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.

CLINICAL TRIAL- NCT01907100

Nintedanib (BIBF 1120) in Mesothelioma

Official Title- LUME-Meso: Double Blind Randomized, Multicentre, Phase 11/111 Study of Nintedanib in Combination with Pemetrexed /Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination with Pemextred/ Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients with Unresectable Malignant Pleural Mesothelioma.

Listing on www.clinicaltrials.gov

Sponsor: Boehringer Ingelheim

Location: Multiple locations throughout the world. In the United States, there are 10 different locations.

University of Alabama at Birmingham Alabama 35249
University of California San Francisco California 94115
Rocky Mountain Cancer Centers, Colorado Springs, Colorado 80907
Comprehensive Cancer Centers of Nevada- Peak Office Henderson, Nevada 89052
University of Pittsburg Medical Center, Pittsburg Pennsylvania 15232
Greenville Health System, Greenville South Carolina 29615
University of Texas MD Anderson Cancer Center, Houston Texas 77030
Texas Oncology McAllen Texas 78503
Texas Oncology San Antonio Northeast San Antonio Texas 78217
Cancer Care Northwest Centers, PS Spokane Valley, Washington 99216

Principal Investigator: Giorgio V. Scagliotti MD, PhD, university of Torino Italy and Nicholas J. Vogelzang MD, Comprehensive Cancer Centers of Nevada- in the United States

Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Number of Participants: Estimated – 537 – September 19, 2013 – October 30,2019

Purpose: This is a Phase ll/lll study to confirm that by adding nintedanib (BIBF 1120) in combination with first line therapy pemextred and cisplatin in one arm of the study- and a second arm having the first line therapy pemextred and cisplatin along with a placebo instead of Nintedanib.

The study will then primarily measure progression free survival measured by the time of randomization for the trial until disease progression, or death from any cause, whichever happens first. The time frame for this follow up is up to 3 years.

The secondary outcomes that will be measured are overall survival measured from the time of randomization to the time of death of any cause. Objective response according to the modified RECIST score. Disease control measured according to modified RECIST by disease control rate. The time frame on all these objectives is up to 3 years.

Screening: 18 years or older- male or female

Not have sarcomatoid sub type of malignant pleural mesothelioma

Eligibility Criteria: Histologically confirmed malignant pleural mesothelioma – Phase ll epithelioid or biphasic subtype only- Phase lll epithelioid subtype only

Life expectancy of at least 3 months- decision by the investigator
Eastern Cooperative Oncology Group (EGOG) score of 0 or1
Measurable disease according to modified RECIST (Response Evaluation in Solid Tumors) criteria

Exclusion Criteria: Previous systemic chemotherapy for malignant pleural mesothelioma

Prior treatment with Nintedanib or any other prior line of therapy

Phase ll patients with sarcomatoid subtype malignant pleural mesothelioma or Phase

lll patients with biphasic or sarcomatoid subtype malignant pleural mesothelioma

Patients with symptomatic neuropathy

Radiotherapy (except extremities) within 3 months prior to baseline imaging

Active brain metastases (e.g. stable for < 4 weeks)

Radiographic evidence of cavitary or necrotic tumors or local invasion of major blood

Vessels by malignant pleural mesothelioma

Significant cardiovascular diseases

Inadequate hematologic, renal, or hepatic function

How the Research Study is Designed to Work: By administering Nintedanib and a placebo to two different randomized groups of patients who have epithelial type malignant pleural mesothelioma, along with the first line chemotherapy agents, cisplatin and pemextred. The results will then be analyzed with attention to overall survival, time to progression of disease recurrence, and time toward death by any cause.

Sources: www.ClinicalTrials.gov

MESOTHELIOMA CLINICAL TRIAL REVIEW – DANA-FARBER CANCER INSTITUTE (BOSTON, MASSACHUSETTS)

Posted on August 25, 2017 by Ellie and Lisa

For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

Listing-Clinical Trial.gov – NCT03075527

Title– A Phase 2 Study of Durvalumab in Combination with Tremelimumab in Malignant Pleural Mesothelioma

Official Title– A Phase 2 Study of Durvalumab in Combination with Tremelimumab in Malignant Pleural Mesothelioma

Sponsor- Dana-Farber Cancer Institute

Astra Zeneca- collaborator

Location- Dana-Farber Cancer Institute Boston Massachusetts

Principle Investigator– Mark M Awad MD Dana-Farber Cancer Institute

Contact- Mark M. Awad, MD, PhD 617 632 3468 mark_awad@dfci.harvard.edu

Patients will receive Durvalumab and tremelimumab both intravenous infusion once per day for every 28-day cycle. Participant s will receive tremelimumab for up to 4 cycles beginning with cycle 5 day 1. Patients will continue to receive durbalumab alon until clinical or radiological progression of disease

Tremelimumab blocks a receptor on immune cell that normally suppresses immune attack

Durvalumab is a drug that block a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cell

Number of Participants-40 Start Date April 10, 2017 Estimated Study Completion September 30, 2024

Purpose– The study is studying two immunotherapies as possible treatment for malignant pleural mesothelioma. Those drugs are Durvalumab and Tremelimumab. This is a phase 11 clinical trial

Eligibility Criteria– 18 Years and older

Inclusion Criteria:

Written informed consent prior to any study-specific procedures not considered part of routine medical care
Histologically or cytological confirmed unresectable or medically inoperable malignant pleural mesothelioma
Disease progression after treatment with at least one line of chemotherapy that include a first line platinum agent in combination with an anti-folate
Participants must have measurable disease according to modified RECIST for pleural malignant mesothelioma. (Bone metastasis are not considered measurable) Prior radiation to the only site of measurable disease will make the participant ineligible unless the lesion has been demonstrated to grow after the completion of radiation therapy
Participants must be willing to undergo a biopsy at the start of this study and an on –treatment biopsy if safe and feasible
Participants must be at least 28 days from any major surgery
ECOG performance status of 0 to 1
Patients must t have adequate hematologic renal, organ and marrow function
Must be 18 years and older
Female and Males who are of childbearing ages must consent to one form of contraception from the time of screening and must continue until 180 days after last dose of investigational product.
Patient is willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination including follow up

Exclusion Criteria–

previous treatment with an immune checkpoint inhibitor, CTLA-4, PD-1, or PD-L1, including prior treatment with either durvalumab or tremelimumab
Known central nervous system metastasis. Patients with known brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease may be enrolled if they have been treated, and are no longer taking corticosteroids and have been stable in imaging for at least 3 weeks
Patient receiving corticosteroids doses greater than 10 mg per day for more than 14 days
Patients receiving other systemic immunosuppressive drugs for more than 14 days
Patients with a history of interstitial lung disease or pneumonitis that has required steroid administration
Active or prior documented autoimmune disease within the past 2 years including but not limited to systemic lupus erythematosus, sarcoidosis syndrome, or Wegener’s granulomatosis Patients with Grave’s disease or psoriasis not requiring systemic treatment within the past 2 years not excluded
Inflammatory bowel disease or any other serious gastrointestinal condition associated with diarrhea
History of primary immunodeficiency
History of allogenic organ transplant
History of hypersensitivity to tremelimumab, durvalumab or any excipient
Know history of tuberculosis
Receipt of live attenuated vaccination within 3o days prior to study entry or within 30 days of receiving durvalumab or trememlimumab
Patient with history of secondary primary malignancy. If patient had curative malignancies with no recurrence within 5 years prior to study. Resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any type.
Patient who have had chemotherapy, biologic therapy or investigational therapy with 21 days including bevizumab or radiotherapy with 7 days prior to entering the study or those who have not recovered from adverse events due to the administration of these agents
If you have received any previous immunotherapy agent with adverse event at least or greater than grade 3
You cannot receive any other investigational agents
Active infections, gastritis symptomatic heart failure, hypertension, ( sbp greater than 160/100with medications)
Unstable angina
Cardiac arrhythmia
Active bleeding diatheses
Active peptic ulcer disease
Psychiatric illness or social situations that would limit compliance with study
Mean QT interval corrected for heart rate greater than 470 ms calculated from 3 electrocardiograms using Frederica’s correction
Known history of HIV
Acute or chronic hepatitis B or hepatitis C
Pregnant women
If involved with planning and/or conduct of Astra Zeneca staff and or staff at the study site
If patient has had a pneumonectomy
How the research Study is Designed to Work

Phase 11 clinical trial tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. The drugs durvalumab or tremelimumab are being studied to see how the drugs help as compared to the usual treatment for malignant mesothelioma.

Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.

Tremelimumab blocks a receptor on immune cells that normally suppress immune attack.

Both of these drugs have been used for treatment of malignant mesothelioma, but the combination has not been tried in treatment in mesothelioma. They have been used successfully together in melanoma.

Sources:

www.ClinicalTrials.gov

With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating is able, the only way to progress to a cure for mesothelioma is through clinical trials.

Please do not hesitate to contact us with any questions.

MESOTHELIOMA CLINICAL TRIAL REVIEW – INTRAPLEURAL CRYOTHERAPY FOR MALIGNANT PLEURAL MESOTHELIOMA

Posted on June 6, 2017 by Ellie and Lisa

Clinical Trial – NCT 02464904

Official Title: Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Listing on: www.clinicaltrials.gov

Sponsor: Mayo Clinic

Location: Mayo Clinic Rochester, Minnesota

Principal Investigator: Shanda H Blackmon, MD, MPH Mayo Clinic

Contact: Karlyn Pierson, RN, MAN 507-538-1960 pierson.karlyn@mayo.edu

Bettie Lechtenberg, MBA 507-266-4819 lechtenberg.bettie@mayo.edu

Purpose: To see if neoadjuvant cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger a systemic and or local pro-inflammatory response in the induction of anti-tumor immunity.

Primary outcome Measure Number of patients with adverse events. Patients will be monitored for adverse events that may have resulted from a pleuroscopy procedure.

Estimated Enrollment 15

Study Start time July 2015

Estimated study completion date June 2017

Estimated Primary completion date June 2017

The study is still open and actively recruiting

Interventions: Patient will have their blood drawn prior to pleuroscopy for staging purposes. The biopsy will consist of pleural fluid and pleural biopsies that will have consist of 4-8 biopsies. During the procedure, there will be 2-3 applications of cryospray applied to the disease. (Usually the chest wall area). The minimum area is a 2×2 cm area which will continue for 15-20 seconds then thaw for 60 seconds followed by 1 to 2 times of cryotherapy before moving on to the next area. The freezing procedure will be video recorded and freezing locations and times will be recorded. Approximately 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care. Blood and pleural fluid and tissue collection will be performed as well.

Description: Patient that have been diagnosed or thought to have malignant pleural mesothelioma. Prior to surgery for treatment a pleuroscopy or video camera exam of the pleura will be conducted to establish diagnosis or extent of the disease. The purpose of this research is to gather information on the safety and effectiveness for cryotherapy in patients with malignant pleural mesothelioma.

Eligibility: Must be 18 years old male or female

Inclusion Criteria

Patients provide informed consent
Patients 18 years of age
Patients competent for making informed decisions
Patient will undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma.
Pregnancy test is required to be negative
Patient is mentally capable of understanding process of study

Exclusion Criteria

Patient that have an INR 1.5 or greater
If patient is on anticoagulants such as heparin, warfarin, and other types of anticoagulation have not been held for the standard time
Vital signs will be stable heart rate greater than 120 unless deemed stable with these values by the surgical or interventional pulmonary attending physician. Also, systolic blood pressure will also not be less than 90 mmHG unless deemed stable
Hypoxia with oxygen saturation less than 88% or a PA02 less than 60 measured from arterial blood gas.
Participating in another study involving the investigational drugs or investigational medical devices
If there is limited access to the pleural space or absence when performing medical pleuroscopy
Inability to read and understand the necessary study documents

Sources:

www.ClinicalTrials.gov

Please do not hesitate to contact us with any questions.

Definition of Terms

Cryotherapy- is the therapeutic use of cold, is a technique that uses extremely cold liquid or an instrument to freeze and destroy abnormal cells. Used on common benign conditions such as warts and certain skin cancers.

Pleuroscopy- is the examination of the pleural cavity with an endoscope, through an incision on the thorax (chest).

Cryospray- the use of liquid nitrogen spray in cryosurgery

Cryosurgery- an operation using freezing temperature as an agent or an independent agent in an instrument to destroy tissue. It is the destruction of tissue using extreme cold: silver nitrate, and carbon dioxide are commonly used.

Source: www.medical-dictionary

MESOTHELIOMA CLINICAL TRIAL REVIEW – NYU IMMUNOTHERAPY

Posted on May 16, 2017 by Ellie and Lisa

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov

Our goal is to feature one mesothelioma clinical trial monthly and break down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

CLINICAL TRIAL- NCT02718911

A Study of LY-33022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors

Official Title- A Phase 1a/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination With Durvalumab (MED14736) or Tremelimumab in Patients With Advanced Solid Tumors

Listing on www.clinicaltrials.gov

Sponsor: Eli Lilly and Company – Collaborator Astra Zeneca

Location: Multiple locations throughout the world

Principal Investigator: Leena Gandhi M.D.at NYU – Study Director 1-877-285-4559 at Eli Lilly

Contact: NYU- 212 731 6199

Number of Participants: Estimated 178

Purpose: -The focus of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimmab in patients with advanced solid tumors

Screening: – Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies

Lab test that include:

absolute neutrophil count> 1.5 x 10.9/Liters
Platelet count. 100,000/ cubic millimeters
Hemoglobin >9 gams per decliter
Serum creatine, 1.5 x institutional upper limit of normal (ULN)
Total billrubin <1.5 x institutional ULN
- Asparate aminotransferase (AST) and alanine aminotransferase (ALT), <2.5x institutional ULN or <5 x institutional ULN for participans with liver metastasis
- International normalized ratio (INR) or prothrombin time (PT) INR, 1.5 x institutional ULN or PT <% seconds above institutional ULN

Eligibility Criteria: Must have histological or cytological evidence of a diagnosis of cancer that is not amendable to curative therapy

Part B must have a type of malignancy that is being studied

Part A (all cohorts): Have the presence of measurable and/ or no measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)

Part B (all cohorts) Have the presence of measurable disease as defined by the RECIST

PTT or activated partial thromboplastin time (aPTT) < 5 seconda above institutional ULN

Thyroid stimulating hormone (TSH) or free thyroxine (T4) within the normal limits

Have a performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria: Are currently receiving or have used immunosuppressive medications within 28 days

Have symptomatic central nervous system (CNS) malignancy or metastasis

Have had any prior Grade>3 immune-related adverse event while receiving any previous immunotherapy agent

Have experienced a Grade>3 AE or a neurologic or ocular AE while receiving prior immunotherapy

How the Research Study Is Designed to Work: Trying to find the maximum dose tolerated by patients of drug LY3022855 when given in combination with Durvalumab- one group – another group LY3022855 and Tremelimumab. One group given escalating doses, the endpoint would be the maximum tolerated dose and measure the response through progression of disease, stable disease, complete response or death.

Sources: www.ClinicalTrials.gov

Please do not hesitate to reach out with any questions.

Definition of Terms

Phase 1a/1b- initial phase of testing of an investigational drug in humans. Used to determine the side effects of the drug and how it works. Phase 1 is sometimes sub-divided into phases 1a and 1b with different doses being measured. New drug being combined with standard of care to find out what dose is best tolerated

Colony- stimulating factor 1 receptor (CSF-1R)- protein encoded by this gene is the receptor for colony stimulating factor 1- cytokine which controls the production, differentiation and function of macrophages. macrophages are important cells of the immune system that are formed in response to an infection. They are large specialized cells that recognize engulf and destroy target cells.

LY3022855- Human monoclonal antibody designed to target CSF1R, preventing ligands CSF1. Being investigated in phase 1 clinical trials, including a collaboration clinical trial with another immuno-oncology agent.

Durvalumab- another name is Imfinzi-ANTI pd-L1 antibody- blocks PD-l1 binding to PD-1 and CD 80- monoclonal antibody being used in treatment of some cancers

Tremelimumab- human immunoglobulin (Ig) G2 monoclonal antibody directed against the human T-cell receptor protein cytotoxic T-lymphocyte- associated protein 4 (CTLA4 with potential immune checkpoint inhibitory and antineoplastic activities.

Solid Tumor- is an abnormal mass of tissue that usually does not contain cysts or liquid area. Solid tumors may be benign (not cancer), or malignant (cancer). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumors.

Source www.cancer.gov

MESOTHELIOMA CLINICAL TRIAL REVIEW- GENETICALLY MODIFIED T CELLS IN TREATING PATIENTS WITH STAGE III-IV NON- SMALL CELL LUNG CANCER OR MESOTHELIOMA

Posted on February 17, 2017 by Ellie and Lisa

Listing- ClinicalTrials.gov- NCT02408016

Official Title- Phase I/II Study in WT1-Expressing Non- Small Cell Lung Cancer and Mesothelioma, Comparing Cellular Adoptive Immunotherapy With Polyclonal Autologous Central Memory to Naïve CD8+ T Cells That Have Been Transduced to Express a WT1- Specific T-Cell Receptor

Sponsor- Fred Hutchinson Cancer Research Center

Location- Fred Hutch/University of Washington Cancer Consortium Seattle Washington 98109

Principal Investigator-Sylvia M. Lee- 206 288 2274 smlee@fredhutch.org

Contact- Sylvia M. Lee 206 288 2274 smlee@fredhutch.org

Purpose- This phase 1/11 trial studies the side effects and best dose of genetically modified T cells in treating patients with stage 111-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell from patients, called T cells, and modifies their genes in the laboratory so that they are programmed to find cells with WT1 and kill them. The T cells are then given back to the patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack cancer cells. Giving cyclophosphamide and aldesleukin with laboratory – treated T cells may help the body build an immune response to kill tumor cells.

Screening– Documentation of NSCLC or mesothelioma by histopathological sample

Patient must be able to give informed consent
Patient must be able to provide blood and tumor samples and undergo the procedures
Required for this protocol

Eligibility Criteria—Inclusion therapy- Three arms of study- For Arm 1

Patient must express human leukocyte antigen (HLA)- A*0201
Evidence of WT1 tumor expression
Patients must have received at least one line of therapy for NSCLC or mesothelioma or previously documented to have declined therapy

NSCLC patients with a mutation in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) must have demonstrated progression or intolerance to at least one of the corresponding targeted therapies (for example erlotinib or crizotinib)

Bi-dimensionally measurable disease by palpation, clinical exam, or radiological imaging (X-ray, computed tomography (CT) scan, positron emission tomography (PET) scan, magnetic resonance imaging (MRI) or ultrasound)

Ninety days must have passed since the last doses of radiation or chemoradiation treatment involving lung tissue or thorax prior to T cell infusion

Patients treated with prior immunotherapy including and not limited to vaccines, cytokines. T cell stimulating agents, cytokines, T cell stimulating agents, cytoxic T lymphocyte antigen 4 (CTLA4) inhibitors and programmed death (PD)-1 check point inhibitors are allowed on therapy provided they did not have any severe grade 4 toxicities due to prior therapy and any toxicities due to prior therapy should have resolved. If resolvable to less than or equal to grade one

ELIGIBILITY FOR TREATMENT ON ARM 2

Patients must express HLA-A*0201
Evidence of WT 1 tumor expression
Ninety days must have passed since the last definitive doses of radiation or chemoradiation treatment prior to T cell infusion

Exclusion Criteria– EXCLUSION FOR ENROLLMENT / SCREENING (ARMS 1 AND 2)

. Performance status by Eastern Cooperative Oncology Group (ECOG) performance status >=2
Active autoimmune disease in which possible progression during treatment would be considered unacceptable by the investigators
Any condition or organ toxicity deemed by the (PI) or the attending physician to place the patient at unacceptable risk for the treatment of the protocol
Men or women of reproductive ability who are willing to use effective contraception or abstinence; women of childbearing potential must have a negative urine test within two weeks prior to first infusion.
Pregnant women and nursing mothers will be eligible for screening only to test HLA type by saliva or buccal swab and WT1 expression from previously collected tissue sample
Clinically significant and ongoing immune suppression including, but not limited to, systemic immunosuppressive agents such as cyclosporine or corticosteroids

EXCLUSION FOR TREATMENT (ARMS 1 and 2)

Exclusions for the leukapheresis procedure (can be performed later as symptoms resolve)
Infection with or without antibiotic treatment
Recent hepatitis exposure
Pregnancy or nursing
HIV or human T-lymphotropic virus (HTLV) infection
Positive result on standard test for Syphilis
Unable to generate antigen-specific WT1-specific CD8+T cells for infusions; however, the patient will have the option to receive WT1-specific T- cells if a lower than planned number of cells is available
Documented infections or known oral temperatures >38.2 degrees Celsius © fewer than 72 hours prior to receiving study treatment or systemic infection requiring chronic maintenance; the start of treatment may be delayed
Systemic steroids should be stopped 2 weeks before the start of treatment; topical and inhaled steroids are allowed
Untreated central nervous system (CNS) metastasis that are > 1cm or symptomatic are not allowed; (patients with CNS metastases >1 cm or symptomatic that have been treated and demonstrated to be radiologically and clinically stable for at least 4 weeks are allowed
WBC- White blood cells < 2,000/ul
Hemoglobin (Hb) <8 g/dl
ANC- Absolute neutrophil count < 1000/ul
Platelets < 50,000/ul
Creatinine >1.5x the upper limit of normal
Aspartate aminotransferase/ alanine aminotransferase (AST/ALT) > 5x upper limits of normal (ULN)
Bilirubin >3 x ULN that cannot be attributed to NSCLC metastasis
HIV or HTLV infection
New York Heart Association functional class lll-lV heart failure, symptomatic pericardial effusion, stable or unstable angina, symptoms of coronary artery disease (CAD), congestive heart failure, clinically significant hypotension or history of an ejection fraction of =<30%

Clinically significant pulmonary dysfunction, as determined by medical history and physical exam, patients identified will undergo pulmonary functions testing and those with forced expiratory volume in the 1 second (FEV1) < 2.0 L or diffusion capacity of the lungs for carbon monoxide (DLCO) (corrected for Hb) < 50% will be excluded

How the Research Study is Designed to Work- Patients are assigned to 1 of 3 treatment arms. This is a phase 1, dose escalation study of autologous WT1-TCRc4 gene-transduced CD8-positive Tcm/Tn lymphocytes followed by a phase 11 study. Once the cells have been reconstucted the cells are given back to the patient with intent that cells will attack to tumor cells.

Sources: www.ClinicalTrials.gov

Please do not hesitate to contact us with any questions.

MESOTHELIOMA CLINICAL TRIAL REVIEW – HILLMAN CANCER CENTER, UNIVERSITY OF PITTSBURGH

Posted on January 5, 2017 by Ellie and Lisa

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time-consuming barrier to participation. The information about clinical trials is available at www.clinicaltrials.gov.

CLINICAL TRIAL- NCT02151448

ADC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies

Official Title- A Phase ½ Trial Evaluating aDC1 Vaccines Combined With Tumor-Selective Chemokine Modulation as Adjuvant Therapy After Surgical Resection of Peritoneal Surface Malignancies

Listing on www.clinicaltrials.gov

Sponsor: Pawel Kalinski M.D. in collaboration with National Cancer Institute

Location: Hillman Cancer Center Pittsburgh, Pennsylvania

Principal Investigator: David L Bartlett M.D. University of Pittsburgh

Contact: David L. Bartlett MD 412 692 2852 bartlettdl@apmc.edu or Natlaie Streeter BA MSN RN 412 235 1276 streetern@upmc.edu

Number of Participants: 168 participants- Start Date July 2014 Estimated completion December 2017

Purpose: “This trial is to determine the safest dose of a triple combination (chemokine modulatory regimen or CKM) of celecoxib, interferon alpha (IFN), and rinatolimod that can be given with a DC vaccine as treatment of peritoneal surface malignancies ater standard of care surgery.

Eligibility Criteria:

18 years of age candidate for surgical reconstruction. Patient has confirmed malignancy of the peritoneum. Patients may have had extensive prior treatments. An ECOG performance status of 0.1 or 2
Patient must be able to swallow pills.
Patient must have normal organ function as defined below
Platelets greater than 75000, hemoglobin greater than 9/0 hematocrit greater than 27

Exclusion Criteria:

use of steroids must be removed at least 3 weeks’ prior administration of vaccination
History of transplant or autoimmune disease
Patients who are pregnant or nursing
Patients with myocardial infarction or ischemia within 3 months prior to
Allergic reactions to or hypersensitivity to Celcoxib or NSAIDs

How the Research Study is Designed to Work:

The trial will evaluate the safety and effectiveness of triple combinations of celecoxib, interferon and rintatolimod that can be given with a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.

The patient must be a surgical candidate with peritoneal mesothelioma. Once this is determined patient will undergo resection at University of Pittsburgh with Dr. Bartlett. While in the operating room, the surgeon will remove a piece of tumor and send it off to the lab. After recovering from surgery patient will have leukaphereses, a lab procedure in which the white blood cells are separated from the blood, it will then be transported to the lab where the tumor is. These two components will be made to form a vaccine. Once recovered from surgery, the treatment of the vaccine will be delivered to the patient. One will be given intradermally (one of the routes of administration used for vaccinations, layer of skin under the epidermis) and one will be given into the lymph nodes. Four weeks after surgery patient will receive intravenous Intraferon which will be given every day, Rintatolimod will be given on Wednesday and Friday of that same week. Celecoxib will be given every day as well during that week. The patient must stay in the Pittsburgh area for these weekly treatments. The goal is to get this regime every 4 weeks. The quality of tumor extracted from the operating room will define how large of a vaccine can be made. If there is residual vaccine it will be up to the patient and team whether administration is continued.

Please contact us if you have any questions.

Mesothelioma Clinical Trial Review – A Phase 1 Study of Concurrent Chemotherapy and Radiation Therapy for Patients with Inoperable Malignant Pleural Mesothelioma

Posted on October 10, 2016 by Ellie and Lisa

For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.

Listing: ClinicalTrial.gov – NCT02639767

Official Title: Concurrent Pemetrexted/ Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unrespectable Malignant Pleural Mesothelioma

Sponsor: Memorial Sloan Kettering Cancer Center

Location: Memorial Sloan Kettering Cancer Center

Principle Investigator: Marjorie Zauderer MD Memorial Sloan Kettering Cancer Center

Contact: Marjorie Zauderer M.D. 646 888 4656
Andreas Rimner M.D. 212 639 6025

Purpose: The purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. This radiation technique is called pleural intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When given after chemotherapy, pleural IMRT has demonstrated promising results with respect to keeping mesothelioma under control longer. However, the investigators want to determine if giving pleural IMRT at the same time is safe. If safe, further studies will be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under control for a longer period of time than chemotherapy followed by pleural IMRT.

Screening: Screening Tests- Pre- treatment MRI before chemo and radiation therapy and will be used for target delineation. Three-month post treatment MRI will be acquired to assess the response from the treatment

Eligibility: Must be pathologically confirmed diagnosis of malignant pleural mesothelioma at Memorial Sloan Kettering Cancer Center

No plans for surgery
Stage T1-4, NO-3, M0
No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
Prior chemotherapy < 1 • Age >18
Karnofsky performance status >80%
Pulmonary function tests as follows: DLCO>50% predicted
Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values
Absolute neutrophil count > 1,500/mcl
Platelets > 100,000/mcl
Calculated creatine clearance (CrCl) > 45ml/min
Serum total bilirubin < 1.5 x upper limit of normal
ASt (SGOT) and ALT (SGPT) < 3.0 x upper limits normal

Exclusion:

Pregnant or lactating women, or men or women not using effective contraception
Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
Patients with a concurrent active malignancy (with the exception of skin cancer)
Patients with serious unstable medical illness
Patients with idiopathic pulmonary fibrosis
Patients with NYHA heart failure class >2
Patients with only one kidney that is ipsilateral to the mesothelioma
Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be removed
Patients meeting the following exclusion criteria will be excluded from the MRI portion only
Metallic implant, e.g. pacemaker, defibrillator
Unmanageable claustrophobia
High risk nephrogenic systemic fibrosis

How the Research Study is Designed to Work- IMRT is a very targeted treatment It is thought that using the two treatments together will improve survival

Sources:

www.ClinicalTrials.gov

With any clinical trial all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.

Please do not hesitate to contact us with any questions.

What is IMRT? Intensity modulated radiation therapy is an advanced form of radiation therapy. Before IMRT patients were radiated in specific areas such as the chest, the radiation was directed at tumors but unfortunately would include healthy tissue. The way it works is that by using computer controlled linear accelerators precise doses of radiation are able to be delivered to a tumor. It targets a specific area within the tumor, by controlling the intensity of the radiation beam to the volume of the tumor. It concentrates the beam in the region within the tumor while minimizing the dose to the surrounding area. This is done by using a CT. Scan or MRI image of the tumor, by doing some computer calculations and 3-D imaging to figure out what dose will conform to the tumor depth and shape. The treatment is usually multiple beams coming from different directions, the dose is customized while minimizing the dose to the adjacent normal tissue.

Pemetrexed/ Cisplatin is the only FDA approved first line chemotherapy for mesothelioma. By combining these therapies within the same time frame the researches are planning to study if working together they improve response and keep the mesothelioma under control for a longer period than if administered seperalty.
This study is being conducted at Memorial Sloan Kettering only. Patients have to be deemed not a candidate for surgery.

Drug Development and Clinical Trials: Importance to Mesothelioma Patients

Posted on September 28, 2016 by Lisa

Recently I had the opportunity to attend a conference regarding drug development from basic research through clinical trials held in Boston. The objective of the conference was to cover the entire drug development process, and to increase awareness of the challenges, and the trends, facing drug research, and development.

One of the conference topics was rare diseases. The working definition of a rare disease in the United States is, “a disease that effects fewer than 200,000 Americans at any given time.” www.fda.org . Mesothelioma can be classified as a rare disease. Some of the other benchmarks of a rare disease also fit a mesothelioma diagnosis. A rare disease can be difficult to diagnose, often leading to a delay in treatment. There is no existing cure- again mesothelioma has no cure. Information is limited on the disease and treatment. There are approximately 7,000 rare diseases, only 5% have active treatments. Patients and their families that have rare diseases, are often searching for clinical trials and in the process become experts on their disease.

The challenges that exist regarding clinical trial information and getting this information to the public’s attention was also discussed. One of the initiatives that will soon be in place is from the Cancer Moon Shot Initiative which involves an improvement at the web site www.clinicaltrials.gov . Plans are being finalized to have the web site become more user friendly for both patient and doctors. There are bio-tech firms working on a way to integrate a clinical trial opportunity into the medical record, alerting both the patient and the MD that they might qualify for a clinical trial.

Support for both patients and families was also discussed. The patient and the family can use the knowledge that they have to spread awareness about the disease. They can use their resources, ask questions, and empower themselves to advance their loved one’s cause.

The mesothelioma community, although small, is a good example for others that suffer from rare diseases. They have raised awareness, are fighting for funding, and help support each other.

On Sunday September 25th on Good Morning America, consumer advocate Erin Brockovich, announced that she was taking mesothelioma on as a cause. She is intent on raising social awareness, to help to wipe out mesothelioma. Mesothelioma and other asbestos related diseases, are a threat to our health and safety. She challenged all of us to get active, empower ourselves, let our voices be heard.

The mesothelioma community is now being joined by a famous consumer advocate. We look forward to her energizing the community!

We recognize the importance of clinical trials to mesothelioma patients. This is why we have created, and updated every three months, the Mesothelioma Clinical Trial Digest, which contains user-friendly information for all clinical trials for pleural and peritoneal mesothelioma in the United States. Let us know if you would like this book or if you need help.

– Lisa

Mesothelioma Clinical Trial Review –Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma

Posted on September 7, 2016 by Ellie and Lisa

Listing- ClinicalTrial.gov- NCT02293005

Official Title- Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma

Sponsor- M.D. Anderson Cancer Center

Millennium Pharmaceuticals Inc.

Location- M.D. Anderson Cancer Center Houston Texas

Principle Investigator- Anne S. Tsao M.D. M.D. Cancer Center

Contact-Anne S. Tsao M.D.- 713- 792-6363

Purpose- To find out if a drug named Alisertib can help control mesothelioma. This is a study investigating the safety of the drug and if it helps in the control of mesothelioma. Alisertib is a drug that targets a protein called aurora A kinase in cancer cells. Alisertib is an inhibitor it is hoped it will target aurora A kinase and kill cancer cells.

Screening– – Lab blood tests- must have an Absolute Neutrophil count (ANC) >1500/mm3, platelets > 100,000mm3, Hgb >9g/dl

Liver function tests – total billirubin <= 1.5 of upper limit of normal etc.

Pathological diagnosis of malignant mesothelioma

Eligibility Criteria– – Voluntary informed consent

Must be 18 or older
Must have measurable disease by modified RECIST or RECIST. Examination for measurable disease completed within 28 days prior to registration
Up to 4 prior lines of systemic therapy (biological or chemotherapy) are allowed
Received at least one prior pemetrexed-based chemotherapy for unrespectable disease, unless within 3 months of receiving platinum pemetrexed therapy for neoadjuvant or adjuvant treatment that has been unsuccessful
Have unresectable malignant mesothelioma- any histology
Diagnosis of malignant mesothelioma- any primary site
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate renal function as defined by: Calculated creatine clearance must be >/= 30 ml/

– Females- either post-menopausal for at least one year before the screening visit- or surgically sterilized, or willing to use an acceptable method of birth control- for the length of the study and at least 1 month after the last dose of alisertib.

Male even if surgically sterilized, agrees to use an acceptable barrier method for contraception, or completely abstain from heterosexual intercourse during the entire study treatment period through 4 months after the last dose of alisertib

Exclusion Criteria-

Prior radiation therapy. Radiation therapy to more than 25% of the bone marrow.
Prior allogeneic bone marrow or organ transplantation
Known GI disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib.
Known history of uncontrolled sleep apneas syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease. Patients who use CPCAP or BIPAP at night and have controlled sleep apnea syndrome are allowed.
Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed.
Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug or other severe infection.
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III of IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Female subject who is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Patient has received other investigational drugs with 14 days before enrollment.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Treatment with clinically significant enzyme inducers, such as enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St John’s wort within 14 days prior to the first dose of alisertib and during the study.
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion. For guidance in defining active infection for hepatitis B, please refer to the WHO guidelines.
Prior administration of an Aurora A kinase-targeted agent, including alisertib.
Receipt of corticosteroids within 7 days prior to the first dose of study treatment, unless patient has been taking a continuous dose of no more that 15mg/day of prednisone for at least 1 month prior to the first dose of study treatment. Low dose steroid use for the control of nausea and vomiting will be allowed. Topical steroid use is permitted. Inhaled steroids are permitted.
Inability to swallow oral medication or inability or unwillingness to comply with the administration requirements related to alisertib.
Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment.
Persons who are incarcerated at time of enrollment (e.g. prisoners) or likely to become incarcerated during the study.

How the Research Study is Designed to Work

The drug Alisertib is taken by mouth twice a day for 7 days in each treatment cycle which is 3 weeks long. After taking the medication for 7 days they do not take the medicine for the next 14 days. The participant is followed by physical exams, blood draws, and every 6 weeks while on the study PET-CT scan of the chest, abdomen, and pelvis to check the status of the disease.

The hope of the researcher is to assess 4- month disease control rate in pre-treated patients that have malignant pleural mesothelioma treated with alisertib

Sources:

www.ClinicalTrials.gov

Please do not hesitate to contact us with any questions.

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