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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043212
Recruitment Status : Withdrawn (Redirection of company goals)
First Posted : August 8, 2002
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):
Northwest Biotherapeutics

August 6, 2002
August 8, 2002
May 1, 2013
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Complete list of historical versions of study NCT00043212 on Archive Site
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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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Prostate Cancer
Drug: Dendritic cell immunotherapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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).
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
DC3-HRPC, October 2001
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Northwest Biotherapeutics
Northwest Biotherapeutics
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Northwest Biotherapeutics
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP