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CompletedNCT00140387Updated Sep 1, 2005

Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®)

A Phase 1/2 interventional study of Immunotherapy allogeneic GM-CSF secreting cellular vaccine in Prostate Cancer, sponsored by Cell Genesys. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-01.

Sponsored by Cell Genesys · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
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Study summary

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.

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Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate
  • Cancer
  • GVAX
  • Metastatic
  • Vaccine
  • Allogeneic cells
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 20 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Cell Genesys is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of adenocarcinoma prostate cancer
  • No evidence of measurable metastatic disease
  • An ECOG performance status of 0 or 1

Exclusion criteria

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants

Interventions

  • BiologicalImmunotherapy allogeneic GM-CSF secreting cellular vaccine
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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00140387
Lead sponsor
Cell Genesys
First posted
Sep 1, 2005
Start date
May 1999
Completion
Mar 2001
Last update
Sep 1, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2005. You cannot join it, but the record below documents what was studied.

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