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

First Received on September 13, 2001. Last Updated on February 6, 2009 History of Changes

Sponsor:	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:	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:

MedlinePlus related topics: Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 1999

Detailed Description:

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 Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 09, 2012