Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

NCT00683319 | Active Not Recruiting

• 3 other identifiers: CDR0000590666CCLG-CNS-2007-09EU-20835
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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)

Interventions

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

methotrexate DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

cognitive assessment PROCEDURE

magnetic resonance imaging PROCEDURE

magnetic resonance spectroscopic imaging PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (10)

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Ototoxicity

Interventions

Carboplatin; Cisplatin; Cyclophosphamide; Methotrexate; Vincristine; Chemotherapy, Adjuvant; Mental Status and Dementia Tests; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Martin W. English, MD

  Birmingham Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: April 1, 2008
• Primary Completion (Estimated): March 1, 2034
• Last Updated: September 20, 2013

Record last verified: 2009-06

Locations

GB (10)