Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024336
First received: September 13, 2001
Last updated: February 6, 2009
Last verified: December 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: tamoxifen citrate Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | August 1999 |
OBJECTIVES:
- Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas.
- Determine the time to neurologic or radiographic progression in patients treated with this regimen.
- Determine the acute and chronic toxicity of high-dose tamoxifen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. Tamoxifen continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | up to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024336
Locations
| Ireland | |
| Our Lady's Hospital for Sick Children | |
| Crumlin, Ireland, 12 | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, WIT 3AA | |
| Hospital for Sick Children NHS Trust | |
| London, England, United Kingdom, WC1N 3JH | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Manchester Children's Hospitals (NHS Trust) | |
| Manchester, England, United Kingdom, M27 1HA | |
| Newcastle Upon Tyne Hospitals NHS Trust | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Llandough Hospital | |
| Penarth, Wales, United Kingdom, CF64 2XX | |
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
| Study Chair: | Anthony Michalski, MD | Great Ormond Street Hospital for Children NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00024336 History of Changes |
| Other Study ID Numbers: | CDR0000068920, CCLG-CNS-1999-06, EU-20123 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
untreated childhood brain stem glioma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013