Status:
COMPLETED
Vaccine Therapy of Prostate Cancer Patients With Recombinant Soluble Prostate-Specific Membrane Antigen (Rs-PSMA) Plus the Immunological Adjuvant Alhydrogel
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
PSMA Development Corp, LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other diseases, ...
Eligibility Criteria
Inclusion
- Non-castrate metastatic patients must have biochemically progressive disease as defined by serial changes in PSA (with a serum testosterone \> or = to 180 ng/mL)following definitive primary therapy such as prostatectomy or radiation. Castrate metastatic patients must have biochemically progressive disease in the absence of radiographic evidence of disease progression with rising PSA values despite castrate (\<50 ng/mL) levels of testosterone following an adequate course of hormonal therapy. An adequate course of hormonal therapy is treatment with an LH-RH analog (with or without an anti-androgen) or orchiectomy.
- Prostate cancer must be histologically confirmed by the Department of Pathology at MSKCC.
- Karnofsky performance status \>70%.
- Patients must have adequate organ function as defined by:
- WBC \> or = to 3000/mm3, neutrophils \> or = to1000/mm3, platelet count \> or = to l00,000 mm3
- Bilirubin \<2.0 mg/dl
- Alkaline Phosphatase and SGOT \<3.0 times the upper limit of normal
- Creatinine \< or = to 2.0 mg/dl
- Hemoglobin \>9.0 g/dl
- ALT \<2.5 times the upper limit of normal
- Patients must be at least 18 years of age
- Expected survival must be \>6 months
- Patients must sign informed consent.
- Non-castrate metastatic patients must have a serum testosterone \>180 ng/mL.
Exclusion
- Radiographic evidence of disease progression.
- Clinically significant cardiac disease (New York Heart Association Class III/IV or severe debilitating pulmonary disease).
- Active CNS or epidural tumor.
- An infection requiring antibiotic treatment.
- Lymphopenia defined by lymphocytes \<1000/mm3.
- Cancer related pain requiring the use of opioid containing analgesics.
- Positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis.
- Concurrent treatment with nutritional or herbal supplements (e.g., PC SPES or similar agents) which could potentially confound the interpretation of study results.
- History of an active secondary malignancy except for non-melanoma skin cancer.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00705835
Start Date
January 1 2003
End Date
January 1 2008
Last Update
January 9 2012
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065