Cancer Clinical Trial
Official title:
Phase I Clinical Trial of Oral Suberoylanilide Hydroxamic Acid - SAHA (MSK390) in Patients With Advanced Solid Tumors and Hematologic Malignancies
RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking
the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of suberoylanilide hydroxamic acid in
treating patients who have advanced cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of suberoylanilide hydroxamic acid in patients
with advanced solid tumors or hematologic malignancies.
- Evaluate the pharmacokinetic profile of this drug in these patients.
- Determine the effects of this drug on absorption in the fasting and non-fasting states
in these patients.
- Determine any anti-tumor effects of this drug in these patients.
- Correlate clinical outcomes with histone acetylation in circulating mononuclear cells
and tumor biopsy samples in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease
(solid tumor vs multiple myeloma or lymphoma vs leukemia or myelodysplastic syndromes).
The initial 15-20 patients (in the solid tumor or multiple myeloma or lymphoma stratum)
receive suberoylanilide hydroxamic acid (SAHA) IV over 2 hours on day 1 of week 0 and then
orally once or twice daily beginning on day 1 of week 1. All remaining patients receive oral
SAHA once or twice daily beginning on day 1 of week 1. Courses repeat every 4 weeks for up
to 1 year in the absence of disease progression or unacceptable toxicity.
In each stratum, 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
at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 114 patients (42 with solid tumors, 36 with lymphoma or
multiple myeloma, and 36 with leukemia or myelodysplastic syndromes) will be accrued for
this study within 1 year.
;
Primary Purpose: Treatment
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