Study Stopped
Redirection of company goals
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
1 other identifier
interventional
N/A
1 country
16
Brief Summary
The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2002
CompletedFirst Posted
Study publicly available on registry
August 8, 2002
CompletedMay 1, 2013
April 1, 2013
August 6, 2002
April 30, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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 0-1.
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2002
First Posted
August 8, 2002
Last Updated
May 1, 2013
Record last verified: 2013-04