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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 8, 2007 | ||||
| Last Updated Date | August 20, 2009 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Maximum tolerated infusion time for high-dose methotrexate [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Maximum tolerated infusion time for high-dose methotrexate | ||||
| Change History | Complete list of historical versions of study NCT00513981 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Plasma biochemical evidence of the systemic effect of methotrexate in terms of changes in plasma homocysteine and methionine [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Plasma biochemical evidence of the systemic effect of methotrexate in terms of changes in plasma homocysteine and methionine | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | High-Dose Methotrexate in Treating Young Patients With Solid Tumors | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 36 | ||||
| Completion Date | |||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY: Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | up to 21 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Ireland, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00513981 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000560133, CCLG-NAG-2005-13, EU-20744, EUDRACT-2005-001757-13 | ||||
| Study Sponsor ICMJE | Children's Cancer and Leukaemia Group | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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