Sarcoma Clinical Trial
Official title:
Phase I Study of High Dose Methotrexate With Simultaneous Trimetrexate and Leucovorin in Patients With Recurrent Osteosarcoma
RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and
leucovorin, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination
chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate
glucuronate when given together with methotrexate and leucovorin in treating patients with
refractory or recurrent osteosarcoma.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of trimetrexate glucuronate when administered with
high-dose methotrexate and leucovorin calcium in patients with refractory or recurrent
high-grade osteosarcoma.
Secondary
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of trimetrexate glucuronate.
Patients receive high-dose methotrexate IV over 4 hours on days 1 and 8 and oral
trimetrexate glucuronate twice daily on days 2-6 and 9-13. Patients also receive leucovorin
calcium IV continuously over 24 hours or orally 2 or 4 times daily on days 9-14. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of trimetrexate glucuronate 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.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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