Expired Study
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Philadelphia, Pennsylvania 19104


RATIONALE: Drugs used in chemotherapy such as sirolimus use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of sirolimus in treating young patients with relapsed or refractory acute leukemia or non-Hodgkin's lymphoma.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of sirolimus in pediatric patients with refractory or relapsed acute leukemia or non-Hodgkin's lymphoma. - Determine the dose-limiting toxic effects of this drug in these patients. - Determine the trough levels produced by this drug in these patients. - Determine the anti-leukemia/lymphoma activity of this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive oral sirolimus once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of sirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.


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



Primary Contact:

Study Chair
Susan Rheingold, MD
Children's Hospital of Philadelphia

Backup Contact:


Location Contact:

Philadelphia, Pennsylvania 19104
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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