A Phase I Study of Triapine in Combination With High Dose Ara-C (Hi-DAC) in Patients With Advanced Hematologic Malignancies

Fecha de inicio: 1 de enero de 2004

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