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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


Phase 2
3 Years
20 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Degree of surgical resection by surgical and radiological assessments

Safety Issue:

No

Principal Investigator

David A. Walker

Investigator Role:

Study Chair

Investigator Affiliation:

Queen's Medical Centre

Authority:

United States: Federal Government

Study ID:

CDR0000454503

NCT ID:

NCT00313521

Start Date:

June 1995

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood cerebellar astrocytoma
  • childhood high-grade cerebral astrocytoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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