| Inclusion Criteria: | 1) Eligibility is restricted to the following subsets of AML (FAB type M0, M1, M2, M4-7, excluding acute promyelocytic leukemia) and high risk myelodysplasia patients (IPSS score of >=1.5, Appendix B).
2) AML patients >= 60 years old who have not received a standard induction regimen containing cytotoxic agents (regimens containing araC or other nucleoside analogues +/- an anthracycline). Low-dose single agent araC, decitabine, or 5-azacytidine regimens will not be considered prior cytotoxic chemotherapy for the purpose of this study.
3) CONTINUATION of # 2: Patients who have received cytotoxic chemotherapy for an antecedent pre-leukemia condition (for example, myelodysplasia) or as curative/adjucant treatment for another malignancy are eligible, provided the chemotherapy was completed > 6 months prior to enrollment on the current trial. Prior treatment with gemtuzumab ozogomicin (Mylotarg) is excluded.
4) Patients with high risk myelodysplasia must be >= 60 years old and cannot have received prior cytotoxic chemotherapy (other than hydroxyurea) for treatment of their myelodysplasia. Low-dose single-agent araC, decitabine, or 5-azacytotoxic regimens will not be considered prior cytotoxic chemotherapy for the purpose of this study. Prior treatment with Mylotarg is excluded.
5) For patients described in # 2, 3, and 4 if a non-cytotoxic agent was administered as a prior anti-leukemic treatment, patients must demonstrate non-response to the prior treatment and must be off the prior anti-leukemia treatment, patients must demonstrate non-response to the prior treatment and must be off the prior treatment for at least 72 hours before beginning treatment on this protocol, and all acute non-hematologic toxicities of prior treatment (with the exception of alopecia or other toxicities not affecting major organ function) must have resolved to <= grade 1.
6) ECOG performance status of 0-2
7) Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods. Pregnant and nursing patients are excluded because the effects of VNP40101M on a fetus or nursing child are unknown.
8) Must be able and willing to give written informed consent.
9) Patients must have the following clinical laboratory values within 24 hours prior to beginning protocol treatment: 1. Serum creatinine <= 2.0 mg/dl. 2. Total bilirubin <= 2.0 mg/dl. 3. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) <= 5x the upper limit of normal. |