Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)
Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started Dec 1998
Shorter than P25 for phase_1 prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedSeptember 1, 2005
August 1, 2005
August 30, 2005
August 30, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
- No evidence of measurable metastatic disease
- An ECOG performance status of 0 or 1
You may not qualify if:
- Transitional cell, small cell or squamous cell prostate carcinomas
- Any previous radiation therapy, prior anti-androgens or prior investigational therapy
- Previous hormonal therapy of any type for prostate cancer
- Previous biological therapy for cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cell Genesyslead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
August 30, 2005
First Posted
September 1, 2005
Study Start
December 1, 1998
Study Completion
February 1, 2001
Last Updated
September 1, 2005
Record last verified: 2005-08