Arsenic Trioxide in Treating Patients With Advanced Solid Tumors
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 arsenic trioxide in treating patients who have advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Drug: arsenic trioxide||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Arsenic Trioxide|
|Study Start Date:||August 1998|
|Study Completion Date:||August 2000|
|Primary Completion Date:||August 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse experience of arsenic trioxide in this patient population. III. Evaluate evidence of clinical responsiveness to this treatment regimen.
OUTLINE: This is a dose escalation, open label study. Patients are stratified by age (pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks. Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity. Patients are followed for at least 1 month after treatment.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003630
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Steven Soignet, MD||Memorial Sloan Kettering Cancer Center|