Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors

NCT ID: NCT00313521

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-06-30

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.

OUTLINE: This is a multicenter study. Patients are stratified by age (3-15 vs 16-20 years of age).

• Chemotherapy: Patients receive thiotepa IV continuously over 168 hours on days 1-7. Treatment repeats every 28 days for up to 2 courses. Patients then proceed to radiotherapy after blood counts recover.
• Radiotherapy: Patients undergo external-beam radiotherapy once daily, 5 days a week, for approximately 6 weeks.
• Post-radiation chemotherapy: Patients with complete, partial, or objective response, or stable disease after 2 courses of thiotepa may receive thiotepa alone for up to 8 more courses at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood cerebellar astrocytoma; childhood high-grade cerebral astrocytoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

thiotepa

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer and Leukaemia Group

OTHER

Sponsor Role: lead

Principal Investigators

David A. Walker

Role: STUDY_CHAIR

Queen's Medical Center

Other Identifiers

CCLG-9405

Identifier Type: -

Identifier Source: secondary_id

EU-20575

Identifier Type: -

Identifier Source: secondary_id

CCLG-CNS-1995-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000454503

Identifier Type: -

Identifier Source: org_study_id