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Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors 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 Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors Clinical research trials and Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors 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 Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors. Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors 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 Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors clinical trial. Test subjects typically receive the most effective healthcare possible for their Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors 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 > "T" Clinical Trials Conditions > Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors  Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
For Condition: stage 4 prostate cancer,recurrent prostate cancer,unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Maryland Greenebaum Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of tributyrin in treating patients with refractory stage IV prostate cancer or other solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and optimum schedule of tributyrin in patients with prostate cancer or other solid tumors. II. Determine the toxic effects of tributyrin in these patients. III. Determine the pharmacodynamics of tributyrin, including modulation of tumor markers, evaluation of clinical remission (when possible), assessment of F-reticulocytes and/or F cells, and evaluation of hemoglobin F before and after treatment, in these patients. IV. Determine the pharmacokinetics of tributyrin, including maximum plasma concentration, terminal half-life, area under the concentration time curve, volume of distribution, and clearance of butyrate, in these patients. V. Determine the relationship between the pharmacokinetics and toxic or therapeutic pharmacodynamic effects of butyrate in these patients. VI. Calculate a tributyrin dose, using results from pharmacokinetic and pharmacodynamic studies, that achieves sustained butyrate concentrations capable of increasing therapeutic effects with reduced toxicity. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive oral tributyrin every 8 hours for 3 weeks. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease may receive additional courses at the discretion of the protocol chairperson. Cohorts of 3-6 patients receive escalating doses of tributyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven prostate cancer or other solid tumor that is refractory to standard treatment or for which no standard therapy exists - Patients with prostate cancer must meet the following conditions: Stage D2 disease; Disease progression after orchiectomy or treatment with leuprolide or flutamide; If no prior orchiectomy, must continue leuprolide or other antiandrogen throughout study - No CNS neoplasms or brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (more than 8 weeks since prior carmustine, mitomycin, or other drugs with delayed toxic effects) and recovered; No prior suramin - Endocrine therapy: See Disease Characteristics; At least 4 weeks since prior flutamide; No concurrent hydrocortisone or other steroids - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent palliative radiotherapy - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: More than 3 months - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL; AST and ALT no greater than 1.5 times normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min - Other: No concurrent medical or psychiatric condition that would preclude study; Able to swallow numerous capsules; Willing to participate in pharmacokinetic studies; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidVan Echo, Study Chair, University of Maryland Greenebaum Cancer Center
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: CDR0000064322; UMCC-9421,NCI-T94-0181O
Study Start Date: August 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002677
Other Recurrent Prostate Cancer Studies:
1. Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors
2. Epothilone D in Treating Patients With Advanced Solid Tumors
3. 3-AP in Treating Patients With Advanced Cancer
4. BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
5. Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
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