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Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy 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 Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy Clinical research trials and Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy 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 Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy 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 Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy clinical trial. Human subjects often receive the most effective healthcare possible for their Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy 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 > "S" Clinical Trials Conditions > Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy  Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
For Condition: Lymphoma,Eye Cancer,Multiple Myeloma,Prostate Cancer,Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering 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 suberoylanilide hydroxamic acid in treating patients who have advanced primary or metastatic solid tumors that have not responded to previous therapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of suberoylanilide hydroxamic acid (SAHA) in patients with advanced malignancies. II. Assess the pharmacokinetic profile of SAHA in these patients. III. Assess the biologic effects of SAHA on normal tissues and on tumor cells in these patients. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive suberoylanilide hydroxamic acid (SAHA) IV over 2 hours for 3 consecutive days. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Accelerated Phase: One patient per dose level receives escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which a patient experiences grade 2 or greater toxicity (other than hemoglobin anemia) with the first course, or when 2 different patients experience a grade 2 toxicity (other than hemoglobin anemia) during any course of treatment. Standard Phase: Cohorts of 3-6 patients receive escalating doses of SAHA until the 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 45 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced primary or metastatic malignancy refractory to standard therapy or for which no curative therapy exists - No progressive metastatic disease requiring palliative therapy within 4 weeks of study - Progressive disease; Increase in preexisting lesions on imaging or physical examination Patients with sole progression criterion of increased biochemical marker (e.g., carcinoembryonic antigen or CA 15-3) or increased symptoms not eligible - Prostate cancer must be either progressive metastatic disease on imaging studies or have rising PSA values; Minimum of 3 rising PSA values obtained at least 1 week apart, or 2 rising PSA values more than 1 month apart, with at least a 25% overall increase; Serum testosterone less than 50 ng/mL; Must maintain castrate status - No active CNS or epidural tumor --Prior/Concurrent Therapy-- - Biologic therapy: Recovered from prior biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: Recovered from prior endocrine therapy; No concurrent ketoconazole in patients with prostate cancer - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherapy to target lesions - Surgery: Not specified - Other: At least 4 weeks since other prior investigational anticancer drugs and recovered --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.0 mg/dL; AST no greater than 37 U/L; PTT no greater than 14 seconds - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No significant cardiac disease (i.e., New York Heart Association class III or IV) - Pulmonary: No severe debilitating pulmonary disease - Other: No infection requiring IV antibiotic treatment; No other severe medical problems that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamKelly, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067789; MSKCC-99059,NCI-H00-0051
Study Start Date: January 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005634
Other Prostate Cancer Studies:
1. Study of the Safety and Efficacy of an Investigational Drug in Adult Patients with Multiple Myeloma
2. The Role of Cyclosporin in Blood Cell Transplants with T-Cell Add-Back for Blood Cancers
3. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
4. CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects with Multiple Myeloma
5. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
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Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
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