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Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

C

Cell Genesys

Status and phase

Completed
Phase 2
Phase 1

Conditions

Prostate Cancer

Treatments

Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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