High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

Children's Cancer and Leukaemia Group

Status and phase: Unknown; Phase 2

Conditions: Brain and Central Nervous System Tumors

Treatments: Procedure: adjuvant therapy; Drug: methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00287924

EU-20581

CCLG-CNS-2005-03

EUDRACT-2004-004405-14

CDR0000454548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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