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