Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513981
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2007-08-08
Brief Title:
High-Dose Methotrexate in Treating Young Patients With Solid Tumors
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
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 6gm² Per 24 Hours of Infusion Time
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 gm² 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 02 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 chromatographymass spectrometry techniques
To determine the maximum tolerated time to exposure to high-dose methotrexate when administered as a continuous infusion at a dose of 6 gm² 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 02 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 chromatographymass spectrometry techniques
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2005-001757-13 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000560133 | REGISTRY | None | None |
| EU-20744 | None | None | None |