Study of Safety and Tolerability of Intravenous CRS-100 in Adults With Carcinoma and Liver Metastases

NCT00327652 | Completed Phase 1 DMC

• 1 other identifier: VAC05001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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 modification to limit cell to cell spread and invasion of liver cells. These attenuations result in decreased virulence of CRS-100 in mice but retain the ability of the investigational agent to stimulate immunity in test animals and generate anti-tumor activity in mice. The primary objective of this study was to determine the maximum tolerated dose (MTD) and to explore the safety profile of a single intravenous dose of CRS-100 in consenting volunteers. Immunological response to CRS-100 and tumor status of study participants were also measured. Participation in this first clinical trial with CRS-100 was restricted to adults with carcinoma refractory to standard treatment (or for whom no standard treatment is available) and who additionally had liver metastases.

Conditions

Neoplasm Metastasis; Liver Neoplasms; Carcinoma

Keywords

carcinoma; liver; hepatic; metastasis; Listeria

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities (DLTs) for 7 days after dosing

  7 days

Interventions

CRS-100 DRUG

Live-attenuated Listeria monocytogenes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anza Therapeutics, Inc.: lead

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Liver Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2008
• Last Updated: April 24, 2008

Record last verified: 2008-04

Locations

US (2)