Study of Safety and Tolerability of Intravenous CRS-207 in Adults With Selected Advanced Solid Tumors Who Have Failed or Who Are Not Candidates for Standard Treatment

Stopped early · Phase 1

Conditions studied: Malignant Epithelial Mesothelioma, Adenocarcinoma of the Pancreas, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of the Ovaries

In brief

This clinical trial will evaluate the safety and tolerability of CRS 207 an investigational product that is a weakened form (attenuated) of Listeria monocytogenes, a type of bacteria that is commonly found in the environment. CRS-207 has been altered in the lab to reduce its ability to cause disease, while maintaining stimulation of the immune system. CRS 207 has also been genetically modified with recombinant DNA to release an antigen called Mesothelin. Because CRS 207 stimulates an immune response to Mesothelin and Mesothelin may be present at higher levels on tumor cells than on normal cells, this clinical trial will also examine if CRS 207 boosts the immune system in a way that targets certain types of cancer. The purpose of this first clinical trial with CRS-207 is to identify an appropriate dose of the investigation agent for later clinical studies and to explore safety when given to consenting adults with advanced cancer of the ovary or pancreas, non-small cell lung cancer, or advanced malignant epithelial mesothelioma. Immunological response to CRS-207 and tumor status of study participants will also be measured. Patients who choose to enter the study must meet all study entry criteria and must have previously failed standard treatment for their cancer. Qualifying study patients will be assigned to receive one of several dose levels of CRS-207. Each patient may receive up to 4 intravenous administrations (21 days apart) of CRS-207 at their assigned dose level.

Key facts

Study ID: NCT00585845
Run by: Anza Therapeutics, Inc.
People needed: 17
Starts: 2007-12-01
Expected to finish: 2009-02-01
Last updated by the study team: 2009-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented malignant epithelial mesothelioma, cancer of the pancreas or ovaries or non-small-cell lung cancer (NSCLC) and who have failed (or are not candidates for) standard therapy
ECOG Performance Status of 0 to 1, or Karnofsky Performance Status (KPS) of 80-100%
Adequate organ function as defined by study-specified laboratory tests
Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
Signed informed consent form
Willing and able to comply with study procedures

You may not qualify if…

History of infection with Listeria, prior vaccination with a listeria-based vaccine, or a positive fecal culture of Listeria at screening
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Allergy to penicillin or yeast or other component of the study drug product (e.g., glycerol)
Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
Artificial (prosthetic) joint or other artificial implant or devices that cannot be easily removed
Certain types of blood transfusions within 14 days prior to receiving study drug or a condition requiring regular blood transfusions more than twice per month
Taking the following medications:
Anti-coagulation medications
Systemically active steroids for more than 2 days within 28 days prior to receiving study drug
More than 325 mg per day of aspirin
More than 2 g per day of acetaminophen
Systemic antibiotics within 14 days prior to receiving study drug
Another investigational product within 28 days prior to receiving study drug
Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
Infection with HIV, hepatitis B or C, or HTLV-1 (human t-lymphotropic virus type 1) at screening
Pregnant or lactating, or close contact with pregnant women or newborn babies
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

Where it is running

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University — Baltimore, Maryland, United States
National Cancer Institute, NCI — Bethesda, Maryland, United States
University of Pennsylvania Abramson Family Cancer Research Center — Philadelphia, Pennsylvania, United States
Hadassah Hebrew University Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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