Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate

DISEASE CHARACTERISTICS:

• Histologically confirmed chronic myelogenous leukemia (CML)
• In chronic phase
• Philadelphia chromosome (Ph)-positive
• No accelerated or blastic phase
• Accelerated phase CML is defined as ≥ 15% but < 30% blasts in peripheral blood or bone marrow OR ≥ 30% blasts and promyelocytes in peripheral blood or bone marrow provided that < 30% blasts were present OR ≥ 20% peripheral basophils OR platelet count < 100,000/mm^3, unrelated to therapy
• No less than 20 metaphases in the bone marrow sample
• No evidence of complete cytogenetic response to imatinib mesylate (complete cytogenetic response defined as 0% Ph-positive cells in bone marrow)
• Receiving continuous imatinib mesylate therapy for ≥ the past 9 months
• Dosage ≥ 600 mg/day for ≥ the past 3 months
• Stable dose of 600 mg/day for ≥ the past 4 weeks
• Achieved and maintained hematological response to imatinib mesylate as defined by all of the following:
• WBC < 20,000/mm^3
• Basophils < 20%
• Less than 5% myelocytes and metamyelocytes in peripheral blood
• No blasts or promyelocytes in peripheral blood
• No evidence of disease-related symptoms or extramedullary disease, including enlarged spleen or liver

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL

Hepatic

• AST and ALT < 1.5 times upper limit of normal (ULN)
• Bilirubin < 1.5 times ULN (except for patients with Gilbert's disease)
• PTT < 1.5 times ULN (except for patients on oral anticoagulation therapy)
• INR < 1.5 times ULN (except for patients on oral anticoagulation therapy)

Renal

• Creatinine < 1.5 times ULN

Cardiovascular

• No angina
• No New York Heart Association class III or IV cardiac disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation
• HIV negative
• No history of non-compliance with medical regimens
• No hypercholesterolemia or hypertriglyceridemia (fasting state) ≥ grade 2 (despite lipid-lowering therapy)
• No diabetes mellitus
• No thyroid dysfunction
• No neuropsychiatric disorders
• No infection
• No other severe and/or uncontrolled medical condition that would preclude study participation
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior allogeneic, syngeneic, or autologous bone marrow transplantation or stem cell transplantation for CML
• No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa)

Chemotherapy

• No prior chemotherapy regimens used in transplantation

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Recovered from prior major surgery

Other

• No prior sirolimus in combination with imatinib mesylate
• At least 4 weeks since prior investigational agents used in combination with imatinib mesylate and recovered
• No other concurrent investigational therapies
• No other concurrent anticancer agents