Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT00003395
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 arsenic trioxide in treating patients who have advanced hematologic cancer.
Detailed Description:
OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate evidence of clinical responsiveness that may provide leads for further testing in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed for 1 month.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Study:
NCT00003395
Study Brief:
Protocol Section:
NCT00003395