Status:
TERMINATED
Phase 1 Trial of Ipilimumab and GVAX in Patients With Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Cell Genesys
Medarex
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE1
Brief Summary
Ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4, and GVAX have demonstrated anti-tumor activity in prostate cancer. Pre-clinical studies with this combination have demonstrated po...
Detailed Description
A promising immunotherapeutic approach in prostate cancer is whole-cell vaccination. Irradiated allogeneic tumor cells expressing GM-CSF generate a long-lasting and specific anti-tumor immunity in pre...
Eligibility Criteria
Inclusion
- Males age 18-80 years
- Histologic diagnosis of adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases by bone scan, CT scan or MRI
- Two consecutive rising PSA values obtained at least two weeks apart and both obtained at least 4-6 weeks after discontinuation of hormone therapy. Second PSA value must be \> 5.0 ng/mL. LHRH agonist should not be discontinued.
- Testosterone \< 50 ng/dL. Must have had orchiectomy or is currently receiving an LHRH agonist.
- WBC \> 3.0 x 109/L, ANC \> 1.5 x 109/L, hemoglobin \> 6.2 mmol/L, and platelets \> 100 x 109/L
- Serum creatinine \< 177 umol/L Bilirubin \< 1.5 times the upper limit of normal AST \< 3 times the upper limit of normal
- ECOG performance status 0-2
- Life expectancy of at least 6 months
- If sexually active, willing to use barrier contraception during the treatment phase of the protocol
- The ability to understand and willingness to sign a written informed consent
Exclusion
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- Bone pain severe enough to require routine narcotic analgesia use
- Clinical evidence of brain metastases or history of brain metastases
- Seropositive for HIV, Hepatitis B antigen positive and/or Hepatitis C viremic
- Prior chemotherapy or immunotherapy for prostate cancer
- Radiation therapy within 4 weeks of the first treatment
- Surgery within 4 weeks of the first treatment. Must have recovered from all side effects.
- Flutamide within 4 weeks of the first treatment Megesterol acetate (Megace), finasteride (Proscar), bicalutamide (Casodex),nilutamide, aminoglutethimide, ketoconazole or diethylstilbestrol within 6 weeks of the first treatment.
- Systemic corticosteroid use within 4 weeks of the first treatment
- History of autoimmune disease
- History of another malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission or any other cancer that has been in complete remission for at least 5 years
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01510288
Start Date
November 1 2004
End Date
November 1 2011
Last Update
January 16 2012
Active Locations (1)
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1
VU university medical center
Amsterdam, Netherlands, 1081 HV