Phase I Study of MGI-114 (NSC#683863) in Patients With Refractory Myelodysplastic Syndromes, Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase (CML-BP)

Date de début de l'étude : 1 juillet 1999

DISEASE CHARACTERISTICS: Diagnosis of refractory myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia MDS and AML include: First salvage with primary refractory disease or first complete remission of no more than 12 months Second or greater salvage After the maximum tolerated dose is determined, AML patients with an intermediate prognosis (i.e., complete remission of more than 12 months, but less than 24 months) are eligible No candidates for curative therapies such as allogeneic bone marrow transplantation PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Bilirubin no greater than 1.5 mg/dL Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months No concurrent grade 4 infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No overt psychosis, mental disability, or other incompetency that would preclude obtaining informed consent No life threatening nonmalignant illness PRIOR CONCURRENT THERAPY: At least 2 weeks since prior biologic therapy and recovered No concurrent systemic anticancer biologic therapy At least 2 weeks since other prior chemotherapy and recovered Concurrent hydroxyurea allowed if needed to control blast counts No concurrent systemic anticancer chemotherapy At least 2 weeks since prior endocrine therapy and recovered Concurrent corticosteroids allowed if needed to control blast counts At least 2 weeks since prior radiotherapy and recovered No concurrent systemic radiotherapy No concurrent surgery At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered No other concurrent investigational drugs