Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
Primary Purpose
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children
Status
Active
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
carboplatin
cisplatin
cyclophosphamide
methotrexate
vincristine sulfate
adjuvant therapy
cognitive assessment
magnetic resonance imaging
magnetic resonance spectroscopic imaging
quality-of-life assessment
Sponsored by
About this trial
This is an observational trial for Brain and Central Nervous System Tumors focused on measuring long-term effects secondary to cancer therapy in children, cognitive/functional effects, ototoxicity, childhood infratentorial ependymoma, childhood supratentorial ependymoma
Eligibility Criteria
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
Sites / Locations
- Birmingham Children's Hospital
- Addenbrooke's Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Royal Liverpool Children's Hospital, Alder Hey
- Great Ormond Street Hospital for Children
- Royal Manchester Children's Hospital
- Queen's Medical Centre
- Children's Hospital - Sheffield
- Aberdeen Royal Infirmary
- Royal Hospital for Sick Children
Outcomes
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT00683319
First Posted
May 21, 2008
Last Updated
September 19, 2013
Sponsor
Children's Cancer and Leukaemia Group
1. Study Identification
Unique Protocol Identification Number
NCT00683319
Brief Title
Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
Official Title
CCLG Observational Study of the Outcome of Ependymoma in Infants Diagnosed Before Their Third Birthday
Study Type
Observational
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2034 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Cancer and Leukaemia Group
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Ototoxicity
Keywords
long-term effects secondary to cancer therapy in children, cognitive/functional effects, ototoxicity, childhood infratentorial ependymoma, childhood supratentorial ependymoma
7. Study Design
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance spectroscopic imaging
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Overall survival
Title
Event-free survival
Title
Response to chemotherapy, if there is residual disease
Title
Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)
Title
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)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin W. English, MD
Organizational Affiliation
Birmingham Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy
We'll reach out to this number within 24 hrs