High-Dose Methotrexate in Treating Young Patients With Solid Tumors
- Conditions
- Brain and Central Nervous System TumorsSarcomaUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00513981
- Lead Sponsor
- Children's Cancer and Leukaemia Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated infusion time for high-dose methotrexate
- Secondary Outcome Measures
Name Time Method Plasma biochemical evidence of the systemic effect of methotrexate in terms of changes in plasma homocysteine and methionine
Trial Locations
- Locations (20)
Royal Manchester Children's Hospital
🇬🇧Manchester, England, United Kingdom
Our Lady's Hospital for Sick Children Crumlin
🇮🇪Dublin, Ireland
Birmingham Children's Hospital
🇬🇧Birmingham, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Children's Hospital - Sheffield
🇬🇧Sheffield, England, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, England, United Kingdom
Sir James Spence Institute of Child Health
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Royal Belfast Hospital for Sick Children
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glasgow, Scotland, United Kingdom
Bristol Royal Hospital for Children
🇬🇧Bristol, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
🇬🇧Liverpool, England, United Kingdom
Childrens Hospital for Wales
🇬🇧Cardiff, Wales, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Royal Aberdeen Children's Hospital
🇬🇧Aberdeen, Scotland, United Kingdom