Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

Sponsor

Children's Cancer and Leukaemia Group (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00683319

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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 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

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Official Title:

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

Study Start Date :

Apr 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2034

Outcome Measures

Primary Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 2 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Great Ormond Street Hospital for Children	London	England	United Kingdom	WC1N 3JH
6	Royal Manchester Children's Hospital	Manchester	England	United Kingdom	M27 4HA
7	Queen's Medical Centre	Nottingham	England	United Kingdom	NG7 2UH
8	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
9	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
10	Royal Hospital for Sick Children	Glasgow	Scotland	United Kingdom	G3 8SJ