High-Dose Methotrexate in Treating Young Patients With Solid Tumors
NCT ID: NCT00513981
Last Updated: 2013-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2007-03-31
2009-08-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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TREATMENT
NONE
Interventions
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leucovorin calcium
methotrexate
mass spectrometry
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* Patients with relapsed ependymoma following the CCLG phase II study of intravenous etoposide (CCLG-CNS-2001-4) or prior to this are eligible at the discretion of the physician
* Patients with relapsed osteogenic sarcoma, other soft tissue sarcomas, or other solid tumors may be suitable for this study at the discretion of the physician
* Radiologically evaluable disease without bone marrow involvement
PATIENT CHARACTERISTICS:
* Lansky performance status (PS) 30-100% (for patients ≤ 12 years of age)
* ECOG PS ≤ 2 (for patients ≥ 13 years of age)
* Life expectancy ≥ 9 weeks
* ANC \> 1,000/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9 g/dL
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN) for age
* Serum total bilirubin normal
* AST or ALT ≤ 2 times ULN
* Glomerular filtration rate ≥ 60 mL/min
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prophylactic trimethoprim-sulfamethoxazole must be stopped 1 week prior to methotrexate administration
Exclusion Criteria
* Concurrent malignancies at other sites
PRIOR CONCURRENT THERAPY:
* Received chemotherapy or biologic therapy within the past 4 weeks
* Received radiotherapy within the past 6 weeks
21 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Eddy J. Estlin
Role: PRINCIPAL_INVESTIGATOR
Royal Manchester Children's Hospital
Locations
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Our Lady's Hospital for Sick Children Crumlin
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
University College Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
Royal Manchester Children's Hospital
Manchester, England, United Kingdom
Sir James Spence Institute of Child Health
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Royal Aberdeen Children's Hospital
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Childrens Hospital for Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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CDR0000560133
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20744
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-001757-13
Identifier Type: -
Identifier Source: secondary_id
CCLG-NAG-2005-13
Identifier Type: -
Identifier Source: org_study_id
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