Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00140387
• Lead Sponsor: Cell Genesys

Brief Summary

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-05
• Study Completion: 2001-03
• Status Verified: 2005-08
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Last Update Submitted: 2005-08-30
• Study First Posted: 2005-09-01
• Last Update Posted: 2005-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of adenocarcinoma prostate cancer
• No evidence of measurable metastatic disease
• An ECOG performance status of 0 or 1

Exclusion Criteria

• Previous hormonal therapy of any type for prostate cancer
• Any previous chemotherapy, or prior investigational therapy for prostate cancer
• Prior Immunotherapy
• Prior treatment with gene therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP