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

Withdrawn before enrolling · Phase 3

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00043212

Run by

Northwest Biotherapeutics

People needed

0

Last updated by the study team

2013-05-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of California, San Diego Medical Center — San Diego, California, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Cancer Centers of Florida, P.A. — Orlando, Florida, United States
• St. Francis Medical Center — Peoria, Illinois, United States
• Louisiana State University — New Orleans, Louisiana, United States
• Clinical Research Solutions — Las Vegas, Nevada, United States
• Albany Regional Cancer Center — Albany, New York, United States
• Carolinas HealthCare System — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Cancer Care Northwest — Spokane, Washington, United States
• St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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