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Vaccine Therapy in Treating Patients With Progressive Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Vaccine Therapy in Treating Patients With Progressive Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Progressive Prostate Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Progressive Prostate Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Vaccine Therapy in Treating Patients With Progressive Prostate Cancer. Vaccine Therapy in Treating Patients With Progressive Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Progressive Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Vaccine Therapy in Treating Patients With Progressive Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Progressive Prostate Cancer  Vaccine Therapy in Treating Patients With Progressive Prostate Cancer
Vaccine Therapy in Treating Patients With Progressive Prostate Cancer
For Condition: stage 4 prostate cancer,recurrent prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): UCSD Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Inserting a gene that has been created in the laboratory into a person's lymphocytes may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have progressiveprostate cancer.
Details: OBJECTIVES: - Determine the safety and feasibility of transgenic lymphocyte immunization vaccine in patients with progressive adenocarcinoma of the prostate. - Determine the maximum tolerated dose of this vaccine in these patients. - Determine the in vivo immunological response to a single dose of this vaccine in these patients. - Determine, preliminarily, the clinical activity of this vaccine in these patients. OUTLINE: This is an open-label, dose-escalation study. - Harvest: On day 0, autologous lymphocytes are harvested and introduced to suitably engineered antigenized antibody genes to generate a transgenic lymphocyte immunization vaccine (TLI). - Patients receive TLI IV over 5 minutes on day 1. Cohorts of 3-6 patients receive escalating doses of TLI until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed on days 2, 7, 16, 23, 30, 58, and 93, at 6 months, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - HLA-A2 positive - Androgen independent - Meets at least 1 of the following criteria: - Progression of bidimensionally measurable disease assessed within the past 12 weeks - Progression of evaluable but not measurable disease (i.e., bone scan) assessed within the past 16 weeks - Prostate-specific antigen (PSA) at least 5 ng/mL (measured within the past 28 days) and rising, defined as at least 2 consecutive increases in PSA measured at least 1 week apart - Surgically or medically castrated - Continued therapy with luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin) required for patients who are medically castrated - Testosterone less than 50 ng/mL (required in patients who have not undergone bilateral orchiectomy) - No metastatic sites other than lymph node or bone PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 6 months Hematopoietic - Granulocyte count at least 1,500/mm^3 - Hemoglobin at least 10 g/dL - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 1.5 times ULN - Hepatitis B and C negative Renal - Creatinine no greater than 1.5 times ULN Other - HIV negative - Fertile patients must use effective barrier contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission - No active major infection - No other significant concurrent active medical illness that would preclude study treatment or survival PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy - No concurrent biologic response modifier therapy Chemotherapy - More than 30 days since prior chemotherapy* - No concurrent chemotherapy NOTE: *Must have demonstrated PSA progression after therapy Endocrine therapy - See Disease Characteristics - At least 28 days since prior flutamide or ketoconazole* - At least 42 days since prior bicalutamide or nilutamide* - More than 30 days since prior corticosteroids greater than replacement doses - No concurrent corticosteroids except for replacement doses for patients with adrenal insufficiency - No concurrent hormonal therapy (other than continuing LHRH therapy) NOTE: *Must have demonstrated progression after therapy Radiotherapy - More than 30 days since prior radiotherapy* - No concurrent radiotherapy NOTE: *Must have demonstrated PSA progression after therapy Surgery - See Disease Characteristics - At least 21 days since prior surgery and recovered Other - More than 30 days since prior immunosuppressive therapy - Concurrent bisphosphonate therapy allowed provided therapy was initiated more than 28 days before study enrollment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrederickMillard, Study Chair, UCSD Cancer Center
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0987
United States
Recruiting Frederick Millard 858-657-7020
Additional Information:
Study ID Numbers: CDR0000309567; UCSD-021436,COSMOB-TLI-CA-TRT-000-IND
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066261
Other Adenocarcinoma Of The Prostate Studies:
1. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
2. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
3. Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
4. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer
5. Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other California Clinical Trials
Other La Jolla Clinical Trials
Vaccine Therapy in Treating Patients With Progressive Prostate Cancer
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