VNP40101M in Treating Patients With Acute Myelogenous Leukemia or High-Risk Myelodysplasia
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myelomonocytic leukemia, myelodysplastic/myeloproliferative neoplasm, unclassifiable, secondary myelodysplastic syndromes, de novo myelodysplastic syndromes, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Acute myelogenous leukemia (AML), meeting the following criteria: In first relapse after first treatment-induced complete remission (CR) (closed to accrual as of 06/09/05) Duration of first CR less than 12 months No prior treatment for first relapse except hydroxyurea FAB type M0, M1, M2, M4-7 No acute promyelocytic leukemia No prior treatment with a standard induction regimen containing cytotoxic agents* (for patients 60 years of age or older) High-risk myelodysplasia, meeting the following criteria: 60 years of age and over No prior cytotoxic chemotherapy* except hydroxyurea Prior gemtuzumab ozogamicin allowed High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE: *Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin ≤ 2.0 mg/dL ALT or AST ≤ 5 times upper limit of normal Chronic hepatitis allowed Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No symptomatic coronary artery disease No uncontrolled arrhythmias No uncontrolled congestive heart failure No other active heart disease Other No uncontrolled active infection Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment Chemotherapy See Disease Characteristics Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Recovered from all prior therapy At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent No concurrent disulfiram (Antabuse) No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts No other concurrent treatment for leukemia, except hydroxyurea used during study treatment No other concurrent investigational drugs
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Duke Comprehensive Cancer Center
- M.D. Anderson Cancer Center at University of Texas
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- King's College Hospital