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Clinical Trial Details

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Malignant Pleural Mesothelioma

Research Study Title

A Phase 1B Study to Evaluate the Safety and Induction of Immune Response of CRS-207 in Combination With Pemetrexed and Cisplatin as Front-line Therapy in Adults With Malignant Pleural Mesothelioma

Purpose

This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such as mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.

To Learn more
Phase

1

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Aduro BioTech, Inc.

Duration

40 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Have histologically confirmed epithelial or biphasic MPM not amenable to potentially curative surgical resection (subjects with biphasic tumors that have a predominantly (≥50%) sarcomatoid component will be excluded)

  • Be at least 18 years of age

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Have an anticipated life expectancy of greater than 6 months

  • For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)

  • Be willing and able to give written informed consent, and be able to comply with all study procedures

  • Have adequate organ function as defined by specified laboratory values

Exclusion Criteria:

  • A candidate for curative surgery

  • Surgery within 2 weeks prior to dosing

  • Prior radiotherapy or biologic therapy

  • Treatment with an investigational agent within 4 weeks before dosing

  • Prior systemic chemotherapy

  • Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions

  • Documented and ongoing brain metastases

  • Have any evidence of hepatic cirrhosis or clinical or radiographic ascites

  • Have clinically significant and/or malignant pleural effusion

  • Known or suspected allergy or hypersensitivity to yeast or any other component of CRS-207 (e.g., glycerol), Platinol or platinum-containing compounds, or pemetrexed

  • Used any systemic steroids within 28 days of study treatment

  • Use more than 3 g/d of acetaminophen

  • An artificial (prosthetic) joint or other artificial implant or device that cannot be easily removed (with some exceptions for dental and breast implants and biliary stents and mediports)

  • Infection with HIV or hepatitis B or C at screening

  • Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment

  • Be a woman who is pregnant or breastfeeding

  • Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen

  • Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Site Locations (5)

Country State City Zip Facility and Contact
United States California San Francisco 94115 University of California at San Francisco
Scott Hammond
415-885-3673
hammonds@cc.ucsf.edu
United States Florida Tampa 33612 H. Lee Moffitt Cancer Center
Germaine M González-Vazquez, BS, CCRP
813-745-8350
germaine.gonzalez-vazquez@moffitt.org
United States Illinois Chicago 60637 University of Chicago Medical Center
Peter Ostiguy, BA
773-834-1472
postiguy@bsd.uchicago.edu
United States Maryland Bethesda 20892 National Cancer Institute
Yvonne Mallory, RN, BSN
301-402-0255
malloryy@mail.nih.gov

Raffit Hassan, MD
Principal Investigator
United States Pennsylvania Philadelphia 19104 University of Pennsylvania Abramson Cancer Center
Mona Jacobs-Small, B.S., RRT, CCRC
215- 662-8632
Mona.Jacobs-Small@uphs.upenn.edu

Contact

Yvonne Malory, RN
301-402-0255

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01675765

Date Last Changed: March 31, 2014

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