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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

NCT00585845 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2009-02-20

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Epithelial Mesothelioma
  • Adenocarcinoma of the Pancreas
  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma of the Ovaries

Interventions

BIOLOGICAL

CRS-207, Live-attenuated Listeria monocytogenes expressing human Mesothelin

2-hour IV infusion once every 21 days, up to 4 doses. Doses from 1x10\^8 cfu to 1x10\^10 cfu.

Sponsors & Collaborators

  • Anza Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dung Thai · Anza Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585845 on ClinicalTrials.gov