NCT00313521UnknownPhase 2
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
Children's Cancer and Leukaemia Group0 sites30 target enrollmentStarted: June 1, 1995Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Degree of surgical resection by surgical and radiological assessments
Study Overview
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 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.
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 and chronic toxicity of thiotepa in these patients.
- Determine the variability in thiotepa metabolism by measuring plasma and cerebrospinal fluid pharmacokinetics of thiotepa and tepa in these patients.
- Develop a phase II study framework model, to determine the chemosensitivity to new, single-agent regimens in the treatment of high-grade (malignant) astrocytic tumors, including anaplastic astrocytoma, glioblastoma, giant cell glioblastoma, and gliosarcoma.
- Determine the incidence of distant neuraxial metastases in patients at the time of relapse.
- Determine the 1-year disease-free survival rate in patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Degree of surgical resection by surgical and radiological assessments
Secondary Outcomes
- Tumor response to chemotherapy by imaging
Investigators
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