High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
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|ClinicalTrials.gov Identifier: NCT00287924|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 7, 2006
Last Update Posted : September 17, 2013
RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: methotrexate Procedure: adjuvant therapy||Phase 2|
- Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.
- Assess the reasons why primary surgery was complete/incomplete in these patients.
- Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.
OUTLINE: This is a multicenter, open-label study.
Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Patients then proceed to further chemotherapy on protocol UKCCSG-CNS-9204.
After completion of study treatment, patients are followed periodically for 9 years.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||March 2010|
- Activity of high-dose methotrexate at 6 weeks
- Assess reasons why primary surgery is complete or incomplete at diagnosis
- Feasibility and toxicity of second look surgery after course 3 at 2 months
- Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287924
|Study Chair:||Martin W. English, MD||Birmingham Children's Hospital|