Status:
ACTIVE_NOT_RECRUITING
Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Eligibility:
All Genders
Up to 2 years
Brief Summary
RATIONALE: Gathering information about how young patients with ependymoma respond to standard combination chemotherapy and learning about the long-term effects of this treatment may help doctors plan ...
Detailed Description
OBJECTIVES: Primary * To determine the overall survival and event-free survival of all infants diagnosed with ependymoma before their third birthday. * To determine the overall survival and event-fr...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed WHO grade 3 anaplastic (malignant) ependymoma or WHO grade 2 ependymoma, including the following variants:
- Papillary
- Cellular
- Clear cell
- Tanycytic
- No myxopapillary ependymoma, subependymoma, or ependymoblastoma
- Meets 1 of the following criteria:
- Has undergone complete resection of the primary tumor (prior to starting chemotherapy)
- Two or more surgical procedures to achieve complete resection allowed
- Metastatic disease at diagnosis (with or without complete resection of the primary tumor)
- Unable to undergo complete resection of the primary tumor (with or without metastatic disease)
- Patients with measurable residual disease (primary or metastatic disease) are eligible provided they undergo treatment on clinical trial CCLG-CNS-2005-03 prior to entering this study
- Has undergone surgical resection OR completed treatment on clinical trial CCLG-CNS-2005-03 within the past 3 weeks
- Patients who are unable to tolerate chemotherapy or who do not receive treatment according to the CCLG guidelines for ependymoma due to parental preference or recommendation from the treating physician are eligible
- PATIENT CHARACTERISTICS:
- Able to tolerate IV hydration
- No active infection
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00683319
Start Date
April 1 2008
Last Update
September 20 2013
Active Locations (10)
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1
Birmingham Children's Hospital
Birmingham, England, United Kingdom, B4 6NH
2
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
3
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
4
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom, L12 2AP