Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma

NCT00024336 | Unknown Phase 2

• 3 other identifiers: CCLG-CNS-1999-06CDR0000068920EU-20123
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 22

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma. PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem glioma

Interventions

tamoxifen citrate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons) * Radiological and clinical diagnostic criteria allowed (biopsy not required) * The following astrocytic tumors are allowed if histologically confirmed: * Diffuse astrocytoma (all subtypes) * Anaplastic astrocytoma * Glioblastoma * Pilocytic astrocytoma (grade I) * Less than 6 months since diagnosis * At least 1 of the following signs of brain stem tumor: * Cranial nerve deficit * Long tract signs * Ataxia * No focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy PATIENT CHARACTERISTICS: Age: * Under 20 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * No frequent vomiting or other medical condition that would preclude oral medication intake PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for brain stem glioma Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * No prior radiotherapy for brain stem glioma Surgery: * Not specified Other: * Concurrent anticonvulsants allowed

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 (22)

Our Lady's Hospital for Sick Children

Crumlin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, United Kingdom

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Hospital for Sick Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Manchester Children's Hospitals (NHS Trust)

Manchester, England, M27 1HA, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Llandough Hospital

Penarth, Wales, CF64 2XX, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Tamoxifen; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Therapeutics

Study Officials

• Anthony Michalski, MD

  Great Ormond Street Hospital for Children NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 1999
• Last Updated: August 7, 2013

Record last verified: 2006-12

Locations

GB (21); IE (1)