CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase

Inclusion Criteria

• •Diagnosis of 1 of the following:
• •* Acute myeloid leukemia
• •* Acute lymphoblastic leukemia
• •* Myelodysplastic syndromes
• •* Refractory anemia with excess blasts \[RAEB\]
• •* RAEB in transformation
• •* Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood/bone marrow blasts
• •* Chronic myelogenous leukemia in blastic phase
• •Disease status must meet 1 of the following criteria:
• •* Primary resistant disease (i.e., failed to achieve a complete response \[CR\] to a prior standard induction regimen)
• •* Relapsed disease after achieving a CR
• •Documented failure to most recent cytotoxic regimen
• •No other potentially curative options
• •No known CNS disease
• •Performance status - ECOG 0-2
• •SGOT or SGPT \< 3 times upper limit of normal\*
• •Bilirubin ≤ 2 mg/dL\*
• •Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No prior allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study compliance
• •No AIDS-defining disease
• •* HIV positive allowed if CD4 counts normal
• •No other concurrent uncontrolled illness
• •No concurrent prophylactic hematopoietic colony-stimulating factors
• •More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered
• •More than 2 weeks since prior radiotherapy and recovered
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent investigational agents
• •No other concurrent anticancer agents or therapies