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Clinical Trial Finder

Search Results

Observing Young Patients With Ependymoma Undergoing Standard Combination Chemotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 2 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00683319
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Cancer and Leukaemia Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martin W. English, MD
Principal Investigator Affiliation Birmingham Children's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Ototoxicity
Additional Details

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.#46;metastatic disease at diagnosis vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Birmingham Children's Hospital, Birmingham, England, United Kingdom

Status

Address

Birmingham Children's Hospital

Birmingham, England, B4 6NH

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Status

Address

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ

Leeds, England, United Kingdom

Status

Address

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF

Liverpool, England, United Kingdom

Status

Address

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP

London, England, United Kingdom

Status

Address

Great Ormond Street Hospital for Children

London, England, WC1N 3JH

Royal Manchester Children's Hospital, Manchester, England, United Kingdom

Status

Address

Royal Manchester Children's Hospital

Manchester, England, M27 4HA

Queen's Medical Centre, Nottingham, England, United Kingdom

Status

Address

Queen's Medical Centre

Nottingham, England, NG7 2UH

Children's Hospital - Sheffield, Sheffield, England, United Kingdom

Status

Address

Children's Hospital - Sheffield

Sheffield, England, S10 2TH

Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom

Status

Address

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN

Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom

Status

Address

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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