NCT00513981

High-Dose Methotrexate in Treating Young Patients With Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors
• Sarcoma
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	leucovorin calcium
DRUG	methotrexate
OTHER	mass spectrometry
OTHER	pharmacological study

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-03-01
• Completion: 2009-08-01
• First posted: 2007-08-09
• Last updated: 2013-06-26

Locations

21 sites across 2 countries: Ireland, United Kingdom