Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140400
• Other study ID #: G-9803
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 30, 2005
• Last updated: August 30, 2005
• Start date: May 1999
• Est. completion date: January 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 a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of adenocarcinoma prostate cancer

• Prostate cancer deemed to be unresponsive or refractory to hormone therapy

• An ECOG performance status of 0 or 1

Exclusion Criteria:

• Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer

• Previous chemotherapy, biological or immunotherapy for cancer

• Previous gene therapy for cancer

• Significant cancer related pain

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