Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
|ClinicalTrials.gov Identifier: NCT00683319|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2008
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Children Ototoxicity||Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: methotrexate Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: cognitive assessment Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: quality-of-life assessment||Phase 3|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||March 2034|
- Overall survival
- Event-free survival
- Response to chemotherapy, if there is residual disease
- Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
- Late effects of treatment (i.e., ototoxicity and nephrotoxicity at the completion of chemotherapy and neurocognitive outcomes at 5, 7, 11, and 16 years of age)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683319
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Royal Liverpool Children's Hospital, Alder Hey|
|Liverpool, England, United Kingdom, L12 2AP|
|Great Ormond Street Hospital for Children|
|London, England, United Kingdom, WC1N 3JH|
|Royal Manchester Children's Hospital|
|Manchester, England, United Kingdom, M27 4HA|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Principal Investigator:||Martin W. English, MD||Birmingham Children's Hospital|