Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy

Phase 1

Completed

• Conditions: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Prostate Cancer; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00005634
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of suberoylanilide hydroxamic acid (SAHA) in patients with refractory 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.

OUTLINE: This is a dose-escalation study. Patients receive suberoylanilide hydroxamic acid (SAHA) IV over 2 hours on days 1-3. 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.

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2000-05-02
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Study First Submitted QC: 2003-12-16
• Study First Posted: 2003-12-17
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States