Status:
TERMINATED
Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating p...
Detailed Description
OBJECTIVES: Primary * Determine the proportion of patients with androgen-independent prostate cancer who are progression-free at one year after treatment with DC-APCC. Secondary * Evaluate treatme...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone \[LHRH\] agonist, or another equivalent hormonal agent)
- Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy)
- Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer)
- PSA 2.0-100.0 ng/mL
- Serum testosterone \< 50 ng/dL (unless undergoing antiandrogen monotherapy)
- No concurrent evidence of radiological or new clinically palpable metastatic cancer
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- WBC ≥ 3,500/µL
- Platelet count ≥ 100,000/µL
- Hemoglobin ≥ 10.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN
- Fertile patients must use effective contraception
- Willing to provide blood samples for research purposes
- Able to complete questionnaire(s) alone or with assistance
- Able to undergo leukapheresis
- No known immunodeficiency
- No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only
- No concurrent serious illness
- No known history of positive PPD skin test
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents
- Inhaled corticosteroids allowed
- More than 1 month since prior and no concurrent estrogens and/or ketoconazole
- More than 3 months since prior and no other concurrent investigational medicinal products
- More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer
- No prior prostate cancer vaccine
- No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy
- No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancy
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00814892
Start Date
January 1 2009
End Date
March 1 2010
Last Update
November 5 2013
Active Locations (1)
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1
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905