Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00683319
• Other study ID #: CDR0000590666
• Secondary ID: CCLG-CNS-2007-09
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 21, 2008
• Last updated: September 19, 2013
• Start date: April 2008

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Cognitive/Functional Effects
• Ependymoma
• Long-term Effects Secondary to Cancer Therapy in Children
• Nervous System Neoplasms
• Ototoxicity

Intervention

Drug:
• carboplatin

• cisplatin

• cyclophosphamide

• methotrexate

• vincristine sulfate

Procedure:
• adjuvant therapy

• cognitive assessment

• magnetic resonance imaging

• magnetic resonance spectroscopic imaging

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Birmingham Children's Hospital	Birmingham	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Royal Hospital for Sick Children	Glasgow	Scotland
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England
United Kingdom	Great Ormond Street Hospital for Children	London	England
United Kingdom	Royal Manchester Children's Hospital	Manchester	England
United Kingdom	Queen's Medical Centre	Nottingham	England
United Kingdom	Children's Hospital - Sheffield	Sheffield	England

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer and Leukaemia Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Primary	Event-free survival			No
Primary	Response to chemotherapy, if there is residual disease			No
Primary	Requirement for radiotherapy (i.e., residual disease at the completion of chemotherapy, progressive disease during chemotherapy, or recurrent disease during or after completion chemotherapy)			No
Primary	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)			Yes