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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years - 20 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00313521
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Children's Cancer and Leukaemia Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David A. Walker
Principal Investigator Affiliation Queen's Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.#46;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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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