Status:
UNKNOWN
Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
3-20 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses...
Detailed Description
OBJECTIVES: Primary * Determine tumor response to adjuvant thiotepa followed by radiotherapy in pediatric patients with newly diagnosed malignant astrocytic tumors. Secondary * Determine the acute...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following high-grade (malignant) astrocytic tumors:
- Anaplastic astrocytoma
- Glioblastoma
- Giant cell glioblastoma
- Gliosarcoma
- Any anatomical site except brain stem
- Newly diagnosed disease
- Has undergone tumor biopsy or surgical resection within the past 2 weeks
- Patients with post-operative residual disease (grade III or IV) are eligible
- Post-operative imaging of tumor within 72 hours of surgery
- Patients with no imageable post-operative disease are not eligible
- No neurological deterioration within 3 days of study treatment
- Increasing requirement for steroids to control symptoms of intracranial pressure is considered evidence of neurological deterioration
- PATIENT CHARACTERISTICS:
- Lansky play score 40-100%
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Creatinine ≥ 1.5 times upper limit of normal
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy
Exclusion
Key Trial Info
Start Date :
June 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00313521
Start Date
June 1 1995
Last Update
September 20 2013
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