RATIONALE: Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase.

Condition	Treatment or Intervention	Phase
adult acute lymphoblastic leukemia adult acute myeloid leukemia childhood acute myeloid leukemia and other myeloid malignancies Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia	Drug: CCI-779  Procedure: chemotherapy	Phase II

OBJECTIVES:

• 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.
• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS: Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• SGOT or SGPT < 3 times upper limit of normal*
• Bilirubin ≤ 2 mg/dL* NOTE: *Unless due to organ leukemic involvement

Renal

• Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

• More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• More than 2 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4095,  United States; Recruiting

Study chairs or principal investigators

Francis J. Giles, MD,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000367093; MDA-2003-0830; NCI-6178
Record last reviewed:  May 2004
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084916
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29