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A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. 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 A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. Clinical research trials and A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. 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 A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.. A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. 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 A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma. 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 > "A" Clinical Trials Conditions > A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.  A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.
A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): Cosmo Bioscience ,
Synopsis: Dr. Frederick Millard, MD, Associate Clinical Professor at the UCSD Cancer Center, will be conducting a 12-week study in advanced prostate cancer patients. The study will be held at the UCSD Medical Center and will test an experimental investigational gene therapy vaccine designed to make the patient's immune system react against telomerase, an enzyme expressed in prostate cancer cells.
Details: The goal of the study is to determine the safety, feasibility, and tolerability of transgenic lymphocyte immunization (TLI). In this process patient's lymphocytes are rendered transgenic for a gene coding for selected portion of telomerase an enzyme expressed in the vast majority of cancer cells. Transgenic cells are then returned to the patient to produce an immune response targeted at cancer cells expressing telomerase. The Phase 1 trial will evaluate TLI in patients with advanced, androgen-independent prostate cancer with metastases confined to lymph nodes or bones.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: Inclusion Criteria: - 18 years of age or older, able to understand and sign the informed consent form. - HLA-A2 positive. - Expected survival 6 months. - Histological evidence of adenocarcinoma of the prostate. - (ECOG) Performance status 0, 1 or 2. The following categories of subjects with androgen-independent prostate cancer are eligible: - Progression of bidimensionally measurable disease assessed within 84 days (12 weeks) prior to enrollment. - Progression of evaluable but not measurable disease (i.e., bone scan) assessed within 112 days (16 weeks) prior to enrollment. - Rising PSA- Rising PSA is defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1). The first rising PSA (measure 2) must be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA is required to be taken and be greater than the second measure. The subject must have a PSA 5 ng/ml in addition to increasing PSA to be eligible. No minimum PSA is required for subjects with measurable disease or non-PSA evaluable disease. - All subjects must have had a CT scan of the abdomen and pelvis within 84 days (12 weeks) prior to enrollment. - All subjects must also have had a bone scan within 112 days (16 weeks) prior to enrollment. - Subjects must have been surgically or medically castrated. If method of castration is LHRH agonists (leuprolide or goserelin), then the subject should be willing to continue the use of LHRH agonists. Castration using LHRH agonist should not be interrupted and subjects who have stopped treatment should be willing to restart. - If the subject has been treated with non-steroidal anti-androgens (flutamide, bicalutamide, nilutamide or ketoconazole), they must have been stopped at least 28 days prior to enrollment for flutamide or ketoconazole and at least 42 days prior to enrollment for bicalutamide or nilutamide and the subjects must have demonstrated progression. - Subjects may have received prior surgery. However, at least 21 days must have elapsed since completion of surgery and subject must have recovered from all side effects. - All subjects must have pre-study PSA within 28 days of enrollment. Subjects must meet the following initial laboratory criteria: - granulocytes 1500/ul - platelet count 100,000/ul - hemoglobin 10 gms/dl - bilirubin 1.5 x ULN - AST 1.5 x ULN - Creatinine 1.5 x ULN - Testosterone < 50ng/ml for those who have not had bilateral orchiectomy - PSA 5ng/ml if no measurable disease
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
FrederickMillard, Principal Investigator, Associate Professor of Medicine at UCSD and Medical Director of the CTO of the UCSD Cancer Center
University of California, San Diego Cancer Center *Recruiting*
San Diego, California, 92093-0987
United States
Recruiting Denise Darrah 858-657-7020
Additional Information:
Study ID Numbers: TLI-CA-TRT-001;
Study Start Date: April 2003
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061035
Other Prostatic Neoplasms Studies:
1. Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
2. Safety and Efficacy of Atrasentan in Men with Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
3. Study of Prostate Cancer in Black and White U.S. Veterans
4. A Phase IIa. Open-label, Multicenter, Dose-escalation Study to Assess the Tolerability and Pharmacokinetics of ZD4054 Given Orally Once Daily in Subjects with Metastatic Prostate Cancer
5. EPO906 Therapy in Patients with Prostate Cancer
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A Phase 1, evaluation of Transgenic Lymphocyte Immunization vaccine in subjects with prostate adenocarcinoma.
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