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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


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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

G-9802

NCT ID:

NCT00140387

Start Date:

May 1999

Completion Date:

March 2001

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Cancer
  • GVAX
  • Metastatic
  • Vaccine
  • Allogeneic cells
  • Prostatic Neoplasms

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