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Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma



Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

For Condition: recurrent childhood acute lymphoblastic leukemia,recurrent childhood lymphoblastic lymphoma,recurrent osteosarcoma,recurrent childhood small noncleaved cell lymphoma,recurrent childhood large cell lymphoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of trimetrexate glucuronate plus leucovorin in treating children who have recurrentacute lymphoblastic leukemia, recurrent osteosarcoma, or refractorynon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate. - Evaluate the toxicity of this treatment regimen in this patient population. OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma). Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy. PROJECTED ACCRUAL: A total of 25 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: - Histologic evidence of one of the following malignancies that has failed conventional therapy: - Acute lymphoblastic leukemia - Non-Hodgkin's lymphoma with bone marrow involvement - Osteogenic sarcoma - In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay PATIENT CHARACTERISTICS: Age: - 21 and under at diagnosis Performance status: - ECOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - Granulocytopenia allowed with bone marrow involvement - Thrombocytopenia allowed with bone marrow involvement - Anemia allowed with bone marrow involvement Hepatic: - (unless due to disease) - Bilirubin no greater than 2.0 mg/dL - AST no greater than 100 Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - No other serious medical illness - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior bone marrow transplantation allowed Chemotherapy: - At least 1 week since prior intrathecal treatment - At least 2 weeks since prior systemic chemotherapy and recovered - At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000) - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy allowed and recovered - No concurrent radiotherapy Surgery: - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
TanyaTrippett,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Gary  Schwartz 212-639-8324


Additional Information:
Study ID Numbers:
  CDR0000064649;  MSKCC-95093,NCI-V96-0840
Study Start Date: 
Record last reviewed: February 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002738

Other Recurrent Childhood Lymphoblastic Lymphoma Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy

2. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

3. Combination Chemotherapy and Rituximab in Treating Young Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

4. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors

5. Comparison of Combination Chemotherapy Regimens in Treating Children Who Have Anaplastic Large Cell Lymphoma

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