Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Radiation Therapy and Tamoxifen in Treating Children With Newly Diagnosed Brain Stem Glioma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | Under 20 | Other | CCLG-CNS-1999-06 EU-20123, NCT00024336 |
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.
Entry 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
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
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
Expected Enrollment
Approximately 60 patients will be accrued for this study within 4 years.
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.
Trial Lead Organizations
Children's Cancer and Leukaemia Group
 | | | ||
| Anthony Michalski, MD, Protocol chair | |
| ||
| ||||
| Registry Information | ||
| ||
| Official Title | Treatment of Children with Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen | |
| ||
| Trial Start Date | 1999-08-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00024336 | |
| ||
| Date Submitted to PDQ | 2001-07-30 | |
| ||
| Information Last Verified | 2006-12-11 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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