3-AP and Cytarabine in Treating Patients With Hematologic Cancer
RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer.
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: cytarabine Drug: triapine||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies|
|Study Start Date:||March 2003|
|Study Completion Date:||January 2008|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
- Determine the feasibility, tolerability, and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies.
- Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients.
- Determine the biological effects of 3-AP and its interaction with cytarabine in these patients.
OUTLINE: This is a pilot, dose-escalation study of cytarabine.
Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response may receive an additional course as consolidation therapy.
Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients receive treatment at that dose.
PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064090
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4095|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|