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Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old

Phase 3
9 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old


- Compare the event free survival as a result of treatment with carboplatin and
vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children
with progressive brain tumors.

- Estimate tumor response rates to each regimen of chemotherapy in these patients.

- Determine toxic effects and quality of life of children treated with each regimen of

- Investigate biological and clinical factors which may predict tumor response and early
progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative
index by MIB-1 (Ki67)) in these patients.

- Investigate factors contributing to neuropsychological and endocrine status of children
with brain tumors treated without irradiation.

OUTLINE: This is a randomized study. Patients are stratified according to site of disease,
status at entry, and pathology. Patients are randomized to one of two treatment arms.
Patients with neurofibromatosis are nonrandomly assigned to arm II.

- Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks
followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance
beginning on day 84 of induction or upon hematopoietic recovery. Each course consists
of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently
with the first 3 weeks of carboplatin), followed by 2 weeks of rest.

- Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4,
followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a
maximum of 8 courses.

PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.

Inclusion Criteria


- Pathologically confirmed low grade residual astrocytomas or other eligible residual
tumors of the brain interpreted as low grade (WHO grades I and II) such as the

- Glial Tumors

- Astrocytic tumors

- Low grade astrocytoma (variants: fibrillary, protoplasmic,

- Pilocytic astrocytoma

- Pleomorphic xanthoastrocytomas

- Subependymal giant cell astrocytoma

- Infantile desmoplastic astrocytoma

- Low grade oligodendroglial tumors

- Low grade oligodendroglioma

- Low grade mixed gliomas

- Oligo-astrocytoma

- Neuronal Tumors

- Ganglioglioma (excluding tumors with anaplastic astrocytic components)

- Infantile desmoplastic ganglioglioma

- Chiasmatic-hypothalamic tumor without histologic confirmation

- All of the following diagnostic tests (radiological or clinical evidence of
progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of
enrollment into this study

- Progressive disease following surgical excision based on clear radiological or
clinical evidence of progression, or an incomplete excision (less than 95% or greater
than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic
impairment with progression

- Chiasmatic lesions that have contiguous extensions of tumor into other regions of the
visual pathways demonstrated on contrast MRI will be eligible for study without
histopathological confirmation

- Patients with neurofibromatosis who have radiographic diagnosis of
chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy
confirmation of tumor histology, but not unless tumor progression is documented

- No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without
definitive involvement of the optic chiasm



- Under 10

Performance status:

- Not specified

Life expectancy:

- Not specified


- Absolute neutrophil count greater than 1,000/mm^3 (arm II)

- Platelet count greater than 100,000/mm^3 (arm II)


- Not specified


- Creatinine less than 1.5 times upper limit of normal for age OR

- Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as
determined by the institutional normal range


Biologic therapy:

- Not specified


- No prior chemotherapy for the tumor

Endocrine therapy:

- Prior corticosteroid therapy allowed


- No prior radiotherapy for the tumor


- See Disease Characterisitcs


- Prior diuretic therapy allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joann Ater, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood brain stem glioma
  • recurrent childhood visual pathway glioma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • childhood low-grade cerebellar astrocytoma
  • childhood low-grade cerebral astrocytoma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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