Clinical Trials Directory

Trials / Completed

CompletedNCT00098891

MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas

A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275 (NSC 706995, IND 61,198), in Combination With 13-Cis-Retinoic Acid in Metastatic Progressive Cancer.

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

Summary

Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may help cancer cells develop into normal cells. MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer. Combining MS-275 with isotretinoin may kill more cancer cells

Detailed description

PRIMARY OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 when administered with isotretinoin in patients with metastatic, progressive, refractory, or unresectable solid tumors or lymphomas. SECONDARY OBJECTIVES: I. Determine, preliminarily, tumor response in patients treated with this regimen. II. Determine the pharmacokinetic profile of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation study of MS-275. Patients receive oral MS-275 once on days 1, 8, and 15 and oral isotretinoin twice daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of MS-275 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. Up to 12 patients are treated at the MTD. Patients are followed monthly.

Conditions

Interventions

TypeNameDescription
DRUGentinostatGiven orally
DRUGisotretinoinGiven orally

Timeline

Start date
2004-10-01
Primary completion
2008-03-01
First posted
2004-12-09
Last updated
2013-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00098891. Inclusion in this directory is not an endorsement.