A Phase II Study Of CCI-779 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase

Study start date: April 1, 2004

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