Trials / Completed
CompletedNCT00140387
Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (planned)
- Sponsor
- Cell Genesys · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immunotherapy allogeneic GM-CSF secreting cellular vaccine |
Timeline
- Start date
- 1999-05-01
- Completion
- 2001-03-01
- First posted
- 2005-09-01
- Last updated
- 2005-09-01
Source: ClinicalTrials.gov record NCT00140387. Inclusion in this directory is not an endorsement.