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Fort Wayne, Indiana 46825

  • Prostate Cancer

Purpose:

The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.


Criteria:

Inclusion Criteria: - Diagnosis of adenocarcinoma of the prostate - Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy - Detectable metastases - ECOG performance status of 0 or 1 Exclusion Criteria: - Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer - Significant cancer related pain - Prior gene therapy, chemotherapy, or immunotherapy


Study is Available At:


Original ID:

G-0010


NCT ID:

NCT00140348


Secondary ID:


Study Acronym:


Brief Title:

Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine


Official Title:

A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cell Genesys


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:


Study Dates

Start Date:December 2001
Completion Date:April 2005
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 18, 2007
First Received Date:August 30, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:Immunotherapy allogeneic GM-CSF secreting cellular

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cell Genesys

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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