Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)
This study has been completed.
Sponsor:
Cell Genesys
Information provided by:
Cell Genesys
ClinicalTrials.gov Identifier:
NCT00140387
First received: August 30, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Cell Genesys:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00140387 History of Changes |
| Other Study ID Numbers: | G-9802 |
| Study First Received: | August 30, 2005 |
| Last Updated: | August 30, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cell Genesys:
|
Prostate Cancer GVAX |
Metastatic Vaccine Allogeneic cells |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013