Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.

• Hormone refractory prostate cancer (HRPC) \– progressive disease despite androgen deprivation and serum testosterone \<50ng/dL; progression defined as either:

  1. 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
  2. Progression of metastatic lesion on bone scan, or
  3. 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).