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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

G-0010

NCT ID:

NCT00140348

Start Date:

December 2001

Completion Date:

April 2005

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Cancer
  • Advanced Prostate Cancer
  • Metastatic
  • Hormone-refractory
  • GVAX
  • Vaccine
  • Allogeneic cells
  • Prostatic Neoplasms

Name

Location

UCSFSan Francisco, California  941430324
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Carle Cancer CenterUrbana, Illinois  61801
Seattle Cancer Care AllianceSeattle, Washington  98109
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Emory UniversityAtlanta, Georgia  30322
South Florida Medical ResearchAventura, Florida  33180
Northeast Indiana ResearchFort Wayne, Indiana  46804-4128
South Orange County Medical Research CenterLaguna Hills, California  92653
Urology San AntonioSan Antonio, Texas  78229
West Coast Clinical ResearchTarzana, California  91356
Virginia Mason Med. Crt.Seattle, Washington  98101