CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, or Chronic Myelogenous Leukemia in Blastic Phase
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)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.