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

April 30, 2013 updated by: Northwest Biotherapeutics

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwest Biotherapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 6, 2002

First Submitted That Met QC Criteria

August 7, 2002

First Posted (Estimate)

August 8, 2002

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC3-HRPC, October 2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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