Clinical Trials Directory

Trials / Completed

CompletedNCT00217412

Vorinostat With or Without Isotretinoin in Treating Young Patients With Recurrent or Refractory Solid Tumors, Lymphoma, or Leukemia

A Phase 1 Study of SAHA (NSC# 701852) in Pediatric Patients With Recurrent or Refractory Solid Tumors (Including Lymphomas) and Leukemia Followed by a Phase I Study of SAHA in Combination With 13-Cis-Retinoic Acid for Patients With Selected Recurrent/Refractory Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
60 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
1 Year – 21 Years
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects and best dose of vorinostat when given together with isotretinoin in treating young patients with recurrent or refractory solid tumors, lymphoma, or leukemia. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Isotretinoin may cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may be an effective treatment for cancer.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGvorinostatGiven orally
DRUGisotretinoinGiven orally

Timeline

Start date
2005-08-01
Primary completion
2009-09-01
Completion
2009-09-01
First posted
2005-09-22
Last updated
2014-06-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00217412. Inclusion in this directory is not an endorsement.