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Active Not RecruitingNCT00683319

Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday

Status
Active Not Recruiting
Phase
—
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Children's Cancer and Leukaemia Group · Academic / Other
Sex
All
Age
2 Years
Healthy volunteers
Not accepted

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 better treatment. PURPOSE: This phase III trial is observing young patients with ependymoma undergoing standard combination chemotherapy.

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-free survival of infants diagnosed with ependymoma before their third birthday when treated with standard chemotherapy comprising vincristine, carboplatin, high-dose methotrexate, cyclophosphamide, and cisplatin. Secondary * To investigate the reasons why the primary tumor was completely resected in patients who were able to undergo complete resection of the tumor. * To continue to investigate the biological characteristics of ependymoma. * To correlate functional imaging studies of ependymoma with biological characteristics of the tumor. * To provide a standard treatment regimen for patients with residual disease after optimal surgery who have already participated in a phase II study. * To prospectively document renal function, hearing, and neurocognitive late effects after completion of study treatment. OUTLINE: This is a multicenter study. Patients are stratified according to extent of prior surgical resection and presence of metastatic disease (complete resection of tumor vs metastatic disease at diagnosis vs no complete resection of tumor). Patients receive vincristine IV on days 1, 15, and 29, carboplatin IV over 1 hour on day 1, high-dose methotrexate\* IV over 24 hours on day 15, cyclophosphamide IV over 1 hour on day 29, and cisplatin IV over 48 hours on days 43 and 44. Treatment repeats every 8 weeks for 7 courses in the absence of disease progression or unacceptable toxicity. Patients with residual disease after completion of treatment may receive other treatment at the discretion of the investigator. NOTE: \*Patients initially treated on clinical trial CCLG-CNS-2005-03 who have no residual disease do not receive high-dose methotrexate in courses 5-7. Patients undergo observational assessments comprising physical and neurological examination; MRI/ MRS scanning of the head and spine; and audiology, renal, endocrine, neurocognitive, and quality of life evaluations periodically for at least 5 years after the completion of study treatment.

Conditions

Interventions

TypeNameDescription
DRUGcarboplatin
DRUGcisplatin
DRUGcyclophosphamide
DRUGmethotrexate
DRUGvincristine sulfate
PROCEDUREadjuvant therapy
PROCEDUREcognitive assessment
PROCEDUREmagnetic resonance imaging
PROCEDUREmagnetic resonance spectroscopic imaging
PROCEDUREquality-of-life assessment

Timeline

Start date
2008-04-01
Primary completion
2034-03-01
First posted
2008-05-23
Last updated
2013-09-20

Locations

10 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00683319. Inclusion in this directory is not an endorsement.