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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 26, 2003

Keywords

ClinConnect Summary

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....

Gender

ALL

Eligibility 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