Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Cytologically confirmed acute myeloid leukemia (AML) meeting the following criteria:
• •* At least 20% of blasts in the bone marrow
• •* AML in first relapse OR refractory to no more than one prior combination of intensive chemotherapy induction regimen
• •No acute promyelocytic leukemia
• •No blast transformation of chronic myeloid leukemia or other myeloproliferative disorders
• •No active CNS leukemia
• •PATIENT CHARACTERISTICS:
• •WHO performance status 0-2
• •Life expectancy ≥ 4 weeks
• •Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)\*
• •AST and ALT ≤ 2.5 times ULN\*
• •Serum creatinine ≤ 1.0 mg/dL\* OR estimated glomerular filtration rate \> 60 mL/min
• •No active uncontrolled systemic infection
• •No concurrent active malignancy
• •No HIV positivity
• •No severe concurrent medical condition or psychiatric disorder that would preclude study participation NOTE: \*Unless due to organ leukemic involvement
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •More than 2 weeks since prior myelosuppressive chemotherapy
• •At least 48 hours since prior hydroxyurea
• •No prior clofarabine or temsirolimus
• •No prior allogeneic stem cell transplantation
• •No investigational drug within the past 30 days