This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments methotrexate, adjuvant therapy
Phase phase 2
Sponsor Children's Cancer and Leukaemia Group
Start date March 2005
End date March 2010
Trial size 29 participants
Trial identifier NCT00287924, CCLG-CNS-2005-03, CDR0000454548, EU-20581, EUDRACT-2004-004405-14


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Activity of high-dose methotrexate at 6 weeks
time frame:

Secondary Outcomes

Assess reasons why primary surgery is complete or incomplete at diagnosis
time frame:
Feasibility and toxicity of second look surgery after course 3 at 2 months
time frame:
Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
time frame:

Eligibility Criteria

Male or female participants up to 2 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed ependymoma, including the following histologic variants: - Cellular - Papillary - Clear-cell - Tanycytic - Anaplastic (malignant) ependymoma - The following diagnoses are excluded: - Myxopapillary ependymoma - Subependymomas - Ependymoblastomas - Primitive neuroectodermal tumors (PNETs) - Other neuroepithelial tumors - Choroid plexus tumors - Germ cell tumors - Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary - Has undergone surgical resection within the past 3 weeks PATIENT CHARACTERISTICS: - At least 3 months to under 3 years of age - Neutrophil count > 1,000/mm^3 - Platelet count > 100,000/mm^3 - Able to tolerate chemotherapy - No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior surgery - No previous chemotherapy - Previous steroids allowed - No previous radiotherapy

Additional Information

Official title Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
Description OBJECTIVES: Primary - Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma. Secondary - 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).