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Biological Therapy in Treating Patients With Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Biological Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Prostate Cancer Clinical research trials and Biological Therapy in Treating Patients With Prostate Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Biological Therapy in Treating Patients With Prostate Cancer. Biological Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Biological Therapy in Treating Patients With Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Biological Therapy in Treating Patients With Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Prostate Cancer  Biological Therapy in Treating Patients With Prostate Cancer
Biological Therapy in Treating Patients With Prostate Cancer
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer
Status: Completed
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Determine the safety of activated autologous T cells (Xcellerate) therapy in patients with hormone-refractory prostate cancer. - Determine the change in prostate-specific antigen (PSA) levels in patients treated with this therapy. - Determine the effects on bone in patients treated with this therapy. OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC). PBMC are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads (Xcellerate). Xcellerate-activated T cells are reinfused on day 0. Patients are followed weekly for 4 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Evidence of androgen-independent disease - Patient must have received prior primary hormonal therapy (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without antiandrogen) - Demonstrated disease progression by any 1 of the following: - Elevated PSA level (at least 5 ng/mL) that has serially risen from baseline on 2 occasions at least 1 week apart - At least 1 new osseous lesion on bone scan - More than 25% increase in the sum of the products of the perpendicular diameters of all bidimensionally measurable sites of disease - No CNS metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - ECOG 0-1 Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGPT no greater than 1.5 times ULN - Hepatitis B surface antigen negative - No active or chronic hepatitis B or C - No other hepatic dysfunction that would preclude study Renal: - Creatinine less than 2.0 mg/dL - Calcium less than 11 mg/dL - No renal dysfunction that would preclude study - No symptomatic hypercalcemia Cardiovascular: - No New York Heart Association class III or IV heart disease Pulmonary: - No pulmonary disease requiring inhaled steroids or bronchodilators Other: - No history of HIV 1 or 2 or human T-cell lymphotrophic virus (HTLV) 1 or 2 - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer - No history of autoimmune disease (e.g., rheumatoid arthritis or multiple sclerosis) - No other major organ system dysfunction - No gastrointestinal, neurologic, or psychiatric dysfunction that would preclude study - Human anti-mouse antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent growth factors, interleukin, interferons, or cytokines Chemotherapy: - No prior chemotherapy or other systemic chemotherapy agent for prostate or any other cancer Endocrine therapy: - Prior aminoglutethimide allowed - At least 4 weeks since prior flutamide - At least 6 weeks since prior bicalutamide or nilutamide - Concurrent luteinizing hormone-releasing hormone agonists should be continued - No concurrent corticosteroids or dexamethasone - No concurrent anti-androgens (e.g., flutamide, bicalutamide, or nilutamide) Radiotherapy: - At least 4 weeks since prior local radiotherapy - No prior radiopharmaceutical therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) - No concurrent radiotherapy Surgery: - Not specified Other: - Prior ketoconazole or PC-SPES allowed - At least 1 week since prior antibiotic, antifungal, or antiviral agents - At least 4 weeks since other prior systemic therapy for prostate cancer (except bisphosphonates or hormonal therapy) - At least 6 weeks since prior investigational drugs or devices - No other concurrent therapy for this disease - No concurrent participation in another clinical trial - No concurrent bisphosphonates unless initiated prior to study - No concurrent immunosuppressive drugs - No other concurrent experimental therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlanPantuck, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1738
United States
Additional Information:
Study ID Numbers: CDR0000069370; UCLA-0111008,NCI-G02-2075,XCYTE-XT002,XCYTE-SPR-080011
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039299
Other Recurrent Prostate Cancer Studies:
1. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
2. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
3. Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
4. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
5. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Biological Therapy in Treating Patients With Prostate Cancer
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