Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias
Leukemia

About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, blastic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, secondary acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Acute myeloid leukemia Acute lymphoblastic leukemia Chronic myelogenous leukemia in blast crisis Relapsed or refractory disease No known standard therapy that is anticipated to result in a durable remission exists CNS leukemia allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT or AST ≤ 3 times ULN Chronic hepatitis allowed Renal Creatinine ≤ 2.0 mg/dL Cardiovascular No active heart disease, including any of the following: Myocardial infarction within the past 3 months Symptomatic coronary artery disease Arrhythmias not controlled by medication Uncontrolled congestive heart failure Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No uncontrolled active infection PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Concurrent hydroxyurea allowed within the first 10 days of study drug administration for control of elevated blast levels or platelet counts Maximum hydroxyurea dose 5 g daily No persistent chronic toxic effects from prior chemotherapy > grade 1 Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Recovered from all prior therapy At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressive disease) No more than 2 leukapheresis procedures within the first 10 days of study drug administration for control of elevated blast levels or platelet counts No concurrent disulfiram No other concurrent anticancer drugs No other concurrent standard or investigational treatment for leukemia
Sites / Locations
- American Health Network - North Illinois Street
- Duke Comprehensive Cancer Center
- Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center