Clinical trial NCT00287924: High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma
Official title: Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: childhood infratentorial ependymoma
childhood supratentorial ependymoma
newly diagnosed childhood ependymoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-02-07
Enrollment: 29
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Activity of high-dose methotrexate at 6 weeks
Secondary outcomes:
measure: Assess reasons why primary surgery is complete or incomplete at diagnosis
measure: Feasibility and toxicity of second look surgery after course 3 at 2 months
measure: Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospital for Sick Children Crumlin
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
state: England
city: Bristol
country: United Kingdom
facility: Institute of Child Health at University of Bristol
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Leeds
country: United Kingdom
facility: Leeds Cancer Centre at St. James's University Hospital
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Children's Hospital, Alder Hey
state: England
city: London
country: United Kingdom
facility: Royal London Hospital
state: England
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
state: England
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Sir James Spence Institute of Child Health at Royal Victoria Infirmary
state: England
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Children's Hospital - Sheffield
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Sutton
country: United Kingdom
facility: Royal Marsden - Surrey
state: England
city: Belfast
country: United Kingdom
facility: Royal Belfast Hospital for Sick Children
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: Cardiff
country: United Kingdom
facility: Childrens Hospital for Wales
state: Wales
Study officials:
affiliation: Birmingham Children's Hospital
name: Martin W. English, MD
role: STUDY_CHAIR
References: