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

Study Overview
=================
Brief Summary
-----------------
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Determine the activity of CCI-779 in patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or chronic myelogenous leukemia in blastic phase. II. Correlate the effect of this drug with altered mitochondrial respiration in the leukemia cells of these patients. OUTLINE: Patients are stratified according to disease (acute myeloid leukemia, myelodysplastic syndromes, chronic myelogenous leukemia in blastic phase [CML-BP] non-lymphoid vs acute lymphoblastic leukemia, CML-BP lymphoid). 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. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 8-46 months.

Official Title
-----------------
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

Conditions
-----------------
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), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia, Secondary Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: temsirolimus
* Other: laboratory biomarker analysis


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (temsirolimus)<br>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. | Drug: temsirolimus<br>* Given IV<br>* Other names: Torisel;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of 20% | The 95% confidence intervals should be provided. | Up to 3 years |