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Ultimate Low Grade Glioma Study

Phase 3
15 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

Ultimate Low Grade Glioma Study

OBJECTIVES: I. Develop a standardized scheme of therapy for children and adolescents with
low grade glioma. II. Determine the effectiveness of carboplatin and vincristine in treating
children aged less than 5 years with severe or progressive symptoms or unequivocal imaging
evidence of tumor growth.

OUTLINE: A complete resection of tumor is performed on patients with low grade glioma with
or without neurofibromatosis type 1. Surgery is reconsidered following tumor relapse,
progression, or clinical deterioration. Every effort is made to obtain a biopsy from
patients not receiving debulking surgery. Nonoperative patients and postoperative patients
who are not candidates for second surgery receive chemotherapy or radiotherapy.
Postoperative patients receive radiotherapy following surgical wound healing and within 28
days of resection. Children less than 5 years old receive chemotherapy first, then
radiotherapy if the tumor subsequently progresses or recurs. All other patients receive
radiotherapy, then chemotherapy. The latter treatment is conducted in the presence of tumor
progression. Chemotherapy is given in 2 parts, first an initial intensive phase (phase 1),
then a later continuation phase (phase 2). In phase 1, patients receive vincristine IV
weekly for 10 weeks and carboplatin IV every 3 weeks. In phase 2, patients receive
vincristine IV and carboplatin IV every 4 weeks for a total treatment time of 52 weeks.
Chemotherapy continues until disease progression or unacceptable toxicity. Patients receive
radiotherapy daily 5 times a week. Patients are followed every 3 months for 1 year, every 6
months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study over 5 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Patients with or without neurofibromatosis type 1 (NF1) with low
grade glioma not previously treated with chemotherapy or radiotherapy Tumor types
considered are: Low grade astrocytoma (Kernohan grade 1/2) Oligodendroglioma Mixed
oligoastrocytoma Ganglioglioma Patients with NF1 and hypothalamic/visual pathway glioma
are eligible without biopsy All CNS sites are eligible, including biopsy proven low grade
spinal tumors and intrinsic brain stem tumors No malignant (anaplastic) glioma (Kernohan
grade 3/4), glioblastoma multiforme, and ependymal tumors

PATIENT CHARACTERISTICS: Age: Under 16 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David A. Walker

Investigator Role:

Study Chair

Investigator Affiliation:

Queen's Medical Centre


United States: Federal Government

Study ID:




Start Date:

January 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood low-grade cerebral astrocytoma
  • childhood oligodendroglioma
  • untreated childhood visual pathway glioma
  • untreated childhood cerebellar astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms