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
temsirolimus
+ laboratory biomarker analysis
Anemia+31
+ Anemia, Refractory
+ Anemia, Refractory, with Excess of Blasts
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.74 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location