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Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Subjects often receive the most expert healthcare possible for their Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy  Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer,stage 4 prostate cancer
Status: No longer recruiting
Sponsor(s): Dendreon ,
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Compare the time to progression, time to development of disease-related pain, and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion. II. Compare response rate and duration of response in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4. Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression. Patients are followed monthly for up to 3 years or until disease progression. At the time of disease progression, patients treated on arm II may receive treatment on Protocol D9903. PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven hormone refractory adenocarcinoma of the prostate that is asymptomatic; Must have soft tissue and/or bony metastases; No visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites) - At least 25% of tumor cells staining positive for prostatic acid phosphatase by immunohistochemistry - PSA at least 5 ng/mL - Tumor progression after hormonal therapy - No cancer related pain and no regular requirement for analgesics --Prior/Concurrent Therapy-- - Biologic therapy: No prior biologic therapy - Chemotherapy: No more than 1 prior chemotherapy regimen - Endocrine therapy: See Disease Characteristics; More than 1 year since prior corticosteroids except replacement systemic steroids and inhaled, intranasal, or topical corticosteroids; No concurrent antiandrogen therapy; Concurrent LHRH agonists allowed - Radiotherapy: No prior radiopharmaceutical therapy; At least 4 weeks since other prior radiotherapy and recovered - Surgery: At least 4 weeks since prior surgery and recovered - Other: No concurrent herbal therapy; Concurrent bisphosphonates allowed if started at least 30 days before enrollment and continued for duration of study --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0 or 1 - Life expectancy: At least 16 weeks - Hematopoietic: WBC at least 2,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); ALT and AST no greater than 5 times ULN; Hepatitis B surface antigen and hepatitis C antibody negative - Renal: Creatinine no greater than 2.0 mg/dL - Other: HIV1, HIV2, and HTLV-1 negative; No active bacterial, viral, or fungal infection; No other malignancy except: Basal cell or squamous cell skin cancer within the past 3 years OR Stage I or II other cancers within the past 5 years; No psychologic, familial, sociologic, geographic, or other medical condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricSmall, Study Chair, Dendreon
Sidney Kimmel Cancer Center
San Diego, California, 92121
United States
Office of Glenn Tisman
Whittier, California, 90601
United States
Cancer Care Northwest
Spokane, Washington, 99202
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
Loma Linda University Medical Center
Loma Linda, California, 92354
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
Center for Medical Oncology
Garden City, New York, 11530
United States
St. Luke's-Roosevelt Hospital
New York City, New York, 10019
United States
New York Medical College
Valhalla, New York, 10595
United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, 18510
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Abington Hematology Oncology Associates, Incorporated
Abington, Pennsylvania, 19001
United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967
United States
Devine Tidewater Urology
Norfolk, Virginia, 23507
United States
AKSM Clinical Research Corporation
Columbus, Ohio, 43214
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200
United States
St. Vincents Comprehensive Cancer Center
New York City, New York, 10011
United States
Office of Barry S. Berman
Orlando, Florida, 32806
United States
Hematology Oncology Northwest, P.C.
Tacoma, Washington, 98405
United States
American Oncology Resources
Dallas, Texas, 75246
United States
Office of Guy Bernstein, M.D.
Bryn Mawr, Pennsylvania, 19010
United States
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, 19010
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Saint Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Eisenhower Medical Center
Rancho Mirage, California, 92270
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
Additional Information:
Study ID Numbers: CDR0000067868; DEN-D9901,NCI-G00-1789
Study Start Date: November 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005947
Other Adenocarcinoma Of The Prostate Studies:
1. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
3. Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
4. Paclitaxel, Estramustine, and Thalidomide in Treating Patients With Progressive Metastatic Androgen-Independent Prostate Cancer
5. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Pennsylvania Clinical Trials
Other Scranton Clinical Trials
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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