Lymphoma Clinical Trial
Official title:
Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia
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.
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.
;
Primary Purpose: Treatment
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