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

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, 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: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.

Detailed Description
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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.

Official Title
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Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia

Conditions
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Leukemia, Lymphoma, Sarcoma

Intervention / Treatment
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* Drug: leucovorin calcium
* Drug: trimetrexate glucuronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: leucovorin calcium|nan|
|Drug: trimetrexate glucuronate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent childhood acute lymphoblastic leukemia, recurrent childhood lymphoblastic lymphoma, recurrent osteosarcoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma