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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwest Biotherapeutics
• Treatments: Hormones

Criteria

Inclusion Criteria

• 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).