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

The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.

Patients with hormone refractory prostate cancer are eligible if they have a rising PSA or three or fewer metastatic lesions. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize a "flag" on prostate cancer cells. This may help the immune system destroy prostate cancer cells. Side effects reported from the Phase I/II trial include skin reactions of redness, pain & swelling at the injection site, and short-lived headache, fever & fatigue. Full details are available in the informed consent.

Inclusion Criteria

• Hormone refractory prostate cancer (HRPC) &#8211; 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).