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Home > "S" Clinical Trials Conditions > Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma  Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
For Condition: recurrent childhood small noncleaved cell lymphoma,recurrent childhood acute lymphoblastic leukemia,recurrent childhood lymphoblastic lymphoma,recurrent childhood acute myeloid leukemia,recurrent childhood large cell lymphoma
Status: Recruiting
Sponsor(s): Children's Hospital of Philadelphia ,
Synopsis: RATIONALE: Drugs used in chemotherapy such as sirolimus use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of sirolimus in treating young patients who have relapsed or refractoryacute leukemia or non-Hodgkin's lymphoma.
Details: 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 1-28. Courses repeat every 28 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry 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 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 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanRheingold, Study Chair, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Susan Rheingold 215-590-2801
Additional Information:
Study ID Numbers: CDR0000321392; CHP-IRB-2002-12-3086,CHP-755
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068302
Other Recurrent Childhood Acute Lymphoblastic Leukemia Studies:
1. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
2. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
3. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
4. Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy
5. MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
Related Studies:
Other recurrent childhood acute lymphoblastic leukemia Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Sirolimus in Treating Young Patients With Relapsed or Refractory Acute Leukemia or Non-Hodgkin's Lymphoma
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