Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140374
• Other study ID #: G-9705A
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 30, 2005
• Last updated: August 30, 2005
• Start date: December 1998
• Est. completion date: February 2001

Study information

• Verified date: August 2005
• Source: Cell Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cell Genesys