Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of vorinostat (SAHA) in young patients with recurrent or refractory solid tumors or lymphomas. II. Determine the MTD of SAHA administered in combination with isotretinoin in young patients with recurrent or refractory neuroblastoma, medulloblastoma/CNS primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. III. Determine the tolerability of the solid tumor MTD of SAHA in young patients with recurrent or refractory leukemia. IV. Determine the toxic effects of SAHA administered with or without isotretinoin in these patients. V. Determine the pharmacokinetics of this drug in these patients. SECONDARY OBJECTIVES: I. Determine, preliminarily, the antitumor activity of SAHA administered with or without isotretinoin in these patients. II. Correlate the pharmacokinetics of this drug with genetic polymorphisms (e.g., UGT1A1) in these patients. OUTLINE: This is a multicenter, dose-escalation study of vorinostat (SAHA). Group 1 (solid tumor or lymphoma patients): Patients receive oral SAHA once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.Cohorts of 3-6 patients receive escalating doses of SAHA 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. An additional 6 patients may be treated at the MTD. Group 2 (leukemia patients): Patients receive SAHA as in group 1 at the MTD. Group 3 (select solid tumor patients): Patients receive oral isotretinoin twice daily on days 1-14. Patients also receive SAHA once daily on days 1-28 OR once on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.The MTD of SAHA is determined as in group 1. An additional 6 patients may be treated at the MTD. After completion of study treatment, patients are followed periodically.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
