Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, oncology, urology, hormone refractory prostate cancer
Eligibility Criteria
Inclusion Criteria Hormone refractory prostate cancer (HRPC) – progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either: Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd measurement, and the 3rd measurement >2.0 ng/ml; or Progression of metastatic lesion on bone scan, or Progression of lymph node metastasis by CT scan. Zubrod or ECOG performance status of 0-1. Three or fewer bone metastases on a bone scan with minimal symptoms. No lymph node lesions greater than 3.0 cm at longest diameter. Adequate hematological, hepatic and renal function. Exclusion Criteria History of other active malignancy. Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months. Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones (e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment. Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness. Prior splenectomy. History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines or any of the antigens included in the skin test. History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke. History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV. Impending untreated spinal cord compression or urinary outlet obstruction. Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
Sites / Locations
- Highlands Oncology Group
- University of California, Los Angeles
- University of California, San Diego Medical Center
- Walter Reed Army Medical Center
- Cancer Centers of Florida, P.A.
- St. Francis Medical Center
- Louisiana State University
- Clinical Research Solutions
- Albany Regional Cancer Center
- Carolinas HealthCare System
- Cleveland Clinic Foundation
- Mary Crowley Medical Research Center
- Tyler Cancer Center
- University of Utah
- Cancer Care Northwest
- St. Luke's Medical Center