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A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas

10 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas



- Determine the feasibility and toxicity of an induction and maintenance regimen
comprising carboplatin, vincristine, and temozolomide in children with progressive
and/or symptomatic low-grade gliomas.


- Determine response rate in patients treated with this regimen.

- Determine 3-year progression-free survival and overall survival of patients treated
with this regimen.

- Correlate response and progression-free survival with the genomic profile of tumors in
patients treated with this regimen.

OUTLINE: This is a pilot study.

- Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and
22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days
43-47. Four weeks after the completion of induction therapy, patients achieving stable
or responding disease proceed to maintenance therapy.

- Maintenance therapy: Patients receive carboplatin and temozolomide as in induction
therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a
total of 6 courses in the absence of disease progression.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Inclusion Criteria


- Histologically confirmed progressive and/or symptomatic low-grade glioma, including
any of the following:

- WHO grade I or II astrocytoma

- Grade I or II oligodendrogliomas

- Mixed oligodendrogliomas

- Gangliogliomas

- Measurable disease

- Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be
removed for anatomical reasons are allowed

- Optic pathway tumors allowed provided there is evidence of progressive disease by MRI
and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary
dysfunction, or diencephalic syndrome

- Dorsally exophytic brainstem gliomas that were previously resected more than 50% are
allowed provided the residual tumor shows progression (with or without symptoms)

- No diffuse brain stem tumors

- No type 1 neurofibromatosis



- 10 and under

Performance status

- ECOG 0-2

- Lansky 50-100%

Life expectancy

- Not specified


- Hemoglobin ≥ 8.0 gm/dL

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT < 2.5 times ULN


- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR

- Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10)


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study


Biologic therapy

- No concurrent immunomodulating agents


- No other concurrent anticancer chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

- No concurrent corticosteroids except for the treatment of increased intracranial


- Not specified


- See Disease Characteristics

- Prior surgery allowed


- No other prior therapy

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of delivering this chemotherapy regimen at 24 weeks

Outcome Description:

Feasibility defined as the ability to administer induction plus one maintenance cycle

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Murali M. Chintagumpala, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

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



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