Expired Study
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Chicago, Illinois 60637


Purpose:

Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug. This phase I trial is studying the side effects and best dose of 3-AP when given with high-dose cytarabine in treating patients with advanced hematologic malignancies


Study summary:

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of 3-AP (Triapine) administered with high-dose cytarabine in patients with advanced hematologic malignancies. SECONDARY OBJECTIVES: I. Determine the clinical activity of this regimen in these patients. II. Determine the effect of treatment with 3-AP (Triapine) on intracellular levels of cytarabine in these patients. OUTLINE: This is a dose-escalation study of 3-AP (Triapine). Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP (Triapine) IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP (Triapine) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per stratum) will be accrued for this study within 15-24 months.


Criteria:

Inclusion Criteria: - Histologically confirmed diagnosis of 1 of the following hematologic malignancies: - Relapsed or refractory acute myeloid leukemia (AML) - Relapsed or refractory acute lymphoblastic leukemia - Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML - Chronic myeloid leukemia in accelerated or blast phase - Refractory to standard therapy or no standard therapy exists - No known brain metastases - Performance status - CALGB 0-2 - Performance status - Karnofsky 60-100% - No G6PD deficiency - Bilirubin < 2.0 mg/dL (unless due to Gilbert's syndrome) - AST and ALT < 2.5 times upper limit of normal (ULN) - Creatinine < 1.5 times ULN - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No pulmonary disease requiring oxygen - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs - No neuropathy - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled illness - No concurrent biologic agents - At least 72 hours since prior hydroxyurea - At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - No other concurrent chemotherapy - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy - Recovered from all prior therapy - At least 4 weeks since prior investigational agents - No other concurrent investigational therapy - No other concurrent anticancer therapy - No concurrent combination antiretroviral therapy for HIV-positive patients


NCT ID:

NCT00077181


Primary Contact:

Principal Investigator
Olatoyosi Odenike
University of Chicago Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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