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TG4010 in Treating Patients With Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about TG4010 in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. TG4010 in Treating Patients With Prostate Cancer Clinical research trials and TG4010 in Treating Patients With Prostate Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including TG4010 in Treating Patients With Prostate Cancer. TG4010 in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a TG4010 in Treating Patients With Prostate Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their TG4010 in Treating Patients With Prostate Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > TG4010 in Treating Patients With Prostate Cancer  TG4010 in Treating Patients With Prostate Cancer
TG4010 in Treating Patients With Prostate Cancer
For Condition: adenocarcinoma of the prostate,stage 1 prostate cancer,stage 3 prostate cancer,stage 2 prostate cancer
Status: Completed
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to determine the effectiveness of TG4010 in treating patients who have prostate cancer.
Details: OBJECTIVES: - Determine the clinical activity of TG4010 in patients with adenocarcinoma of the prostate. - Determine the biological activity of this drug in these patients. - Determine the safety of this drug in these patients. - Determine, preliminarily, the relative efficacy of this drug in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive TG4010 subcutaneously (SC) weekly for 6 weeks and then every 3 weeks. - Arm II: Patients receive TG4010 SC every 3 weeks. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity or until no further response to treatment is observed for at least 12 weeks. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A maximum of 50 patients (25 per treatment arm) will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - MUC1 antigen expression by positive staining with H23 monoclonal antibody - Rising prostate-specific antigen (PSA) documented with any of the following: - Rising PSA confirmed by 2 measurements taken at least 1 week apart - PSA doubling time of 6 months or less - Absolute PSA level of at least 2.0 ng/mL - Previously treated with surgery or radiotherapy - No evidence of metastases or locally recurrent disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 6 months Hematopoietic: - WBC at least 3,000/mm3 - Lymphocyte count at least 800/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN Renal: - Creatinine no greater than 2 times ULN Other: - HIV negative - No other malignancy within the past 5 years except nonmelanoma skin cancer - No active systemic infection - No other serious concurrent systemic medical disorder that would preclude study - No allergy to eggs - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunomodulating drugs - No concurrent immunomodulating drugs Chemotherapy: - Not specified Endocrine therapy: - No prior or concurrent hormonal therapy for rising PSA after initial therapy - No concurrent systemic corticosteroids Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics Other: - At least 4 weeks since prior immunosuppressive drugs - At least 4 weeks since prior participation in another experimental study - No concurrent immunosuppressive drugs - No concurrent participation in another experimental study - No other concurrent systemic or local therapy for prostate cancer
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: CDR0000069431; NCI-G02-2089,UCLA-0110008-01A,TRANSGENE-TG4010.03
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040976
Other Adenocarcinoma Of The Prostate Studies:
1. Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
2. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
3. Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
4. Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
5. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
TG4010 in Treating Patients With Prostate Cancer
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