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

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer

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).