Status:
COMPLETED
Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases
Lead Sponsor:
Anza Therapeutics, Inc.
Conditions:
Neoplasm Metastasis
Liver Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This clinical trial evaluated the safety and tolerability of CRS-100, an investigational agent containing a live-attenuated strain of Listeria monocytogenes (Lm). CRS-100 is attenuated by genetic modi...
Detailed Description
Patients who consented to participate in the study were evaluated for eligibility according to their medical history, physical examination, blood testing, and computed tomography (CT) scan of thorax, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (abbreviated):
- Documented carcinoma refractory to standard treatment (or for whom no standard treatment is available). Hepatocellular carcinoma (HCC) is not allowed.
- Hepatic metastases
- ECOG Performance Status of 0 or 1, or Karnofsky Performance Status (KPS) of 80% to 100%.
- Adequate organ function as defined by clinical hematology and chemistry assays.
- Exclusion Criteria (abbreviated):
- Known central nervous system metastases.
- History of allergic reactions attributed to sulfa or beta-lactam antibiotics.
- Cardiac conditions associated with high- or moderate-risk of endocarditis.
- Intra-arterial hepatic catheter, hepatic cirrhosis, or clinically relevant ascites.
- Artificial (prosthetic) joint or other artificial implant or devices that cannot easily be removed.
- Known coagulation disorder or recent thromboembolic event.
- Use of immunosuppressive agent, chemotherapy, or radiation therapy within 28 days prior to CRS-100; bone marrow or stem cell transplant or a major organ allograft; autoimmune disease.
- Current history of gallstones or kidney stones.
- Infection with HIV, human t-lymphotropic virus type 1 (HTLV-1), hepatitis c virus (HCV), or hepatitis b virus (HBV).
- Pregnant or lactating
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00327652
Start Date
October 1 2006
Last Update
April 24 2008
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21231
2
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201