Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	10 and under	NCI	COG-ACNS0223 ACNS0223, NCT00077207

Objectives

Primary

1. 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.

Secondary

1. Determine response rate in patients treated with this regimen.
2. Determine 3-year progression-free survival and overall survival of patients treated with this regimen.
3. Correlate response and progression-free survival with the genomic profile of tumors in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent immunomodulating agents

Chemotherapy

• No other concurrent anticancer chemotherapy

Endocrine therapy

• Prior corticosteroids allowed
• No concurrent corticosteroids except for the treatment of increased intracranial pressure

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics
• Prior surgery allowed

Other

• No other prior therapy

Patient Characteristics:

Age

• 10 and under

Performance status

• ECOG 0-2
• Lansky 50-100%

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 8.0 gm/dL
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT < 2.5 times ULN

Renal

• 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)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation

Expected Enrollment

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

Outcomes

Feasibility of delivering this chemotherapy regimen at 24 and 60 weeks

Progression-free survival at 3 years

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.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Murali Chintagumpala, MD, Protocol chair		Ph: 832-822-4266

Registry Information
Official Title		A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas
Trial Start Date		2004-07-06
Registered in ClinicalTrials.gov		NCT00077207
Date Submitted to PDQ		2003-12-16
Information Last Verified		2007-08-02
NCI Grant/Contract Number		CA98543

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