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Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. Clinical research trials and Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective.. Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective. condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective.  Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective.
Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective.
For Condition: Prostate Cancer
Status: Terminated
Sponsor(s): Northwest Biotherapeutics ,
Synopsis: The purpose of this clinical research study is to assess the safety and efficacy of an investigational therapy called DCVax(TM)-Prostate.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria - Hormone refractory prostate cancer (HRPC) – progressive disease despite androgen deprivation and serum testosterone <50ng/dL; progression defined as either: a. 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 b. Progression of metastatic lesion on bone scan, or c. 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).
Total Enrollment: 495
Location and Contact Information:
Tyler Cancer Center
Tyler, Texas,
United States
Albany Regional Cancer Center
Albany, New York,
United States
St. Luke's Medical Center
Milwaukee, Wisconsin,
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
Cancer Care Northwest
Spokane, Washington,
United States
Highlands Oncology Group
Springdale, Arkansas,
United States
University of Utah
Salt Lake City, Utah,
United States
Clinical Research Solutions
Las Vegas, Nevada,
United States
Louisiana State University
New Orleans, Louisiana,
United States
Cleveland Clinic Foundation
Cleveland, Ohio,
United States
University of California, San Diego Medical Center
San Diego, California,
United States
Carolinas HealthCare System
Charlotte, North Carolina,
United States
University of California, Los Angeles
Los Angeles, California,
United States
Mary Crowley Medical Research Center
Dallas, Texas,
United States
St. Francis Medical Center
Peoria, Illinois,
United States
Additional Information:
Study ID Numbers: DC3-HRPC, October 2001;
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043212
Other Prostate Cancer Studies:
1. Clinical Trial for Prostate Cancer
2. Investigational Drug with Neoadjuvant Hormone Therapy in Patients with High Risk Prostate Cancer
3. A Safety and Feasibility Study of Active Immunotherapy in Patients with Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed with Antigen Encoded in Amplified Autologous Tumor RNA
4. "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
5. Safety and Efficacy Study of Omnitarg (Pertuzumab) to Treat Castration-Resistant Prostate Cancer
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Study of a drug [DCVax (tm)-Prostate] to treat prostate cancer when hormone therapy is no longer effective.
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