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| Sponsored by: |
Children's Cancer and Leukaemia Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024336 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen |
| Study Start Date: | August 1999 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons)
The following astrocytic tumors are allowed if histologically confirmed:
At least 1 of the following signs of brain stem tumor:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Ireland | |
| Our Lady's Hospital for Sick Children | |
| Crumlin, Ireland, 12 | |
| United Kingdom, England | |
| Addenbrooke's NHS Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Bristol Royal Hospital for Children | |
| Bristol, England, United Kingdom, BS2 8BJ | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Manchester Children's Hospitals (NHS Trust) | |
| Manchester, England, United Kingdom, M27 1HA | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, WIT 3AA | |
| Newcastle Upon Tyne Hospitals NHS Trust | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Hospital for Sick Children NHS Trust | |
| London, England, United Kingdom, WC1N 3JH | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Royal Marsden Hospital | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Saint Bartholomew's Hospital | |
| London, England, United Kingdom, EC1A 7BE | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| United Kingdom, Northern Ireland | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| United Kingdom, Scotland | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom | |
| United Kingdom, Wales | |
| Llandough Hospital | |
| Penarth, Wales, United Kingdom, CF64 2XX | |
| Study Chair: | Anthony Michalski, MD | Great Ormond Street Hospital for Children |
More Information
| Study ID Numbers: | CDR0000068920, CCLG-CNS-1999-06, EU-20123 |
| Study First Received: | September 13, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00024336 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated childhood brain stem glioma |
|
Estrogen Antagonists Estrogens Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Central Nervous System Neoplasms Selective Estrogen Receptor Modulators Hormones |
Tamoxifen Estrogen Receptor Modulators Neuroectodermal Tumors Brain Stem Glioma, Childhood Neoplasms, Germ Cell and Embryonal Citrate Neuroepithelioma Glioma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Estrogen Antagonists Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Central Nervous System Neoplasms Selective Estrogen Receptor Modulators |
Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
