NCT00043212WithdrawnPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Northwest Biotherapeutics
- Locations
- 17
Study Overview
Brief Summary
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hormone refractory prostate cancer (HRPC) – 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-
- •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).
Investigators
Study Sites (17)
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