Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed diagnosis of 1 of the following:
• •* Acute lymphoblastic leukemia (ALL) OR acute myeloid leukemia (AML)
• •* At least 25% blasts in the bone marrow
• •* Recurrent or refractory disease
• •* Non-Hodgkin's lymphoma (NHL)
• •* Second or greater relapse as determined by physical or radiological evidence
• •Disease for which there is no known curative therapy
• •PATIENT CHARACTERISTICS:
• •Age
• •21 and under
• •Performance status
• •Karnofsky 50-100% (patients over 10 years of age)
• •Lansky 50-100% (patients 10 years of age and under)
• •Life expectancy
• •At least 4 weeks
• •Hematopoietic
• •Absolute neutrophil count at least 1,000/mm\^3\*
• •Platelet count at least 75,000/mm\^3 (transfusion independent)\*
• •Hemoglobin at least 8.0 g/dL (may receive red blood cells (RBC) transfusions)\* NOTE: \*Patients with ALL, AML, and NHL with tumor metastatic to bone marrow, with granulocytopenia, anemia, and/or thrombocytopenia are eligible, but will not be evaluable for hematological toxicity
• •Hepatic
• •Bilirubin no greater than 1.5 times normal
• •alanine aminotransferase (ALT) no greater than 5 times normal
• •Albumin at least 2 g/dL
• •Renal
• •Creatinine based on age, as follows:
• •* No greater than 0.8 mg/dL (5 years of age and under)
• •* No greater than 1.0 mg/dL (6 to 10 years of age)
• •* No greater than 1.2 mg/dL (11 to 15 years of age)
• •* No greater than 1.5 mg/dL (over 15 years of age) OR
• •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
• •Cardiovascular
• •Shortening fraction at least 28% by echocardiogram OR
• •Ejection fraction at least 50% by gated radionuclide
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Able to ingest oral medication
• •No known allergy to sirolimus, tacrolimus, or other mammalian target of rapamycin (mTOR) inhibitors
• •No uncontrolled active infection
• •* Fungal disease must be stable for at least 2 weeks prior to study entry
• •* Documented negative blood cultures prior to study entry for patients with bacteremia
• •No active graft-versus-host disease
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Recovered from prior immunotherapy
• •More than 1 week since prior hematopoietic growth factors except for epoetin alfa
• •At least 7 days since prior biologic antineoplastic agents
• •At least 3 months since prior bone marrow or stem cell transplantation
• •Chemotherapy
• •Recovered from all prior chemotherapy
• •More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
• •Prior hydroxyurea within the past 2 weeks is allowed provided peripheral blast count has been stable or rising for at least 3 days
• •Endocrine therapy
• •Prior corticosteroids within the past 2 weeks are allowed provided peripheral blast count has been stable or rising for at least 3 days
• •Radiotherapy
• •Recovered from prior radiotherapy
• •At least 2 weeks since prior local palliative radiotherapy
• •At least 4 weeks since prior craniospinal radiotherapy or radiation to the pelvis of 50% or more
• •At least 4 weeks since prior substantial bone marrow radiotherapy
• •No concurrent radiotherapy, except for emergent situations or persistent extramedullary disease with resolution of bone marrow disease
• •Surgery
• •Not specified
• •Other
• •No other concurrent investigational antineoplastic drugs
• •No concurrent administration of any of the following:
• •* Ketoconazole
• •* Tacrolimus
• •* Cyclosporine
• •* Rifampin
• •* Diltiazem