Brain and Central Nervous System Tumors Clinical Trial
Official title:
Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups
Verified date | December 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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 high-energy x-rays to kill tumor cells. Giving chemotherapy and
radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well thiotepa works together with radiation
therapy in treating young patients with newly diagnosed malignant brain tumors.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | November 1997 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 20 Years |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Children's Cancer and Leukaemia Group |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of surgical resection by surgical and radiological assessments | No | ||
Secondary | Tumor response to chemotherapy by imaging | No |
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