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

This study has been withdrawn prior to enrollment.
(Redirection of company goals)
Sponsor:
Information provided by (Responsible Party):
Northwest Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00043212
First received: August 6, 2002
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Dendritic cell immunotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Northwest Biotherapeutics:

Enrollment: 0
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043212

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

Additional Information:
No publications provided

Responsible Party: Northwest Biotherapeutics
ClinicalTrials.gov Identifier: NCT00043212     History of Changes
Other Study ID Numbers: DC3-HRPC, October 2001
Study First Received: August 6, 2002
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwest Biotherapeutics:
prostate cancer
oncology
urology
hormone refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014