Study of a Drug [DCVax (tm)-Prostate] to Treat Prostate Cancer When Hormone Therapy is no Longer Effective.
NCT ID: NCT00043212
Last Updated: 2013-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
NCT02107404
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
NCT02107391
Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
NCT02105675
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
NCT00005992
Autologous Dendritic Cell Therapy for Hormone-Refractory Metastatic Prostate Cancer
NCT01171729
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dendritic cell immunotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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).
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwest Biotherapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Northwest Biotherapeutics, Inc.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DC3-HRPC, October 2001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.