Sarcoma Clinical Trial
Official title:
Study to Determine the Maximum Tolerated Time of Infusion for High-Dose Methotrexate, Administered as a Continuous Intravenous Infusion at a Dose of 6g/m² Per 24 Hours of Infusion Time
RATIONALE: Drugs used in chemotherapy, such as high-dose methotrexate work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Chemoprotective drugs, such as leucovorin calcium, may protect normal cells from
the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of
high-dose methotrexate in treating patients with solid tumors.
OBJECTIVES:
- To determine the maximum tolerated time to exposure to high-dose methotrexate when
administered as a continuous infusion at a dose of 6 g/m² per 24 hours.
- To relate the methotrexate schedules investigated to the magnitude and duration of
changes in plasma homocysteine and methionine.
- To relate evidence of the systemic effect of methotrexate through changes in plasma
homocysteine and methionine to any hepatic, neurological, or antiproliferative toxicity
observed in the study group.
OUTLINE: Patients receive a continuous infusion of high-dose methotrexate IV over 24, 30,
36, or 42 hours depending on time of study entry. Beginning at hour 42 or 48, patients
receive leucovorin calcium IV every 6 hours for 3 days or until plasma methotrexate
concentration is < 0.2 µM. Treatment repeats every 2 weeks in the absence of disease
progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study and analyzed for
pharmacodynamic effects on plasma homocysteine and methionine by gas chromatography/mass
spectrometry techniques.
;
Masking: Open Label, Primary Purpose: Treatment
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