ACNS0223: a pilot study using carboplatin, vincristine and temozolomide for children < 10 years with progressive OR symptomatic low-grade gliomas
Date Last Modified:
Date First Published: 2/28/2007
| Type | Status | Age Range (yrs.) | Sponsor | Protocol ID |
|---|
| Treatment | Active | 10 and under | COG | ACNS0223 |
Outline
This is a pilot study for anti-cancer drug combinations for Carboplatin, Vincristine, and Temozolomide.
- Induction therapy: Patients receive Carboplatin intravenously (IV) over 1 hour on days 1, 8, 15, and 22; Vincristine IV on days 1, 8, 15, 22, 29, and 36; and Temozolomide orally 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.
Objectives
Primary
- 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
- 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.
Projected Accrual
A total of 30-50 patients will be accrued for this study.
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 Patient Characteristics:
Age
Performance status
Life expectancy
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 8.0g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT < 2.5 times ULN
Pancreatic
Renal
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min/1.73m² or
- Creatinine based as follows:
- Less than or equal to 0.8 mg/dL (for patients age 5 and under) or
- Less than or equal to 1.0 mg/dL (for patients age 6 to 10)
Cardiovascular
Pulmonary
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
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
Surgery
- See Disease Characteristics
- Prior surgery allowed
Other
Who should I contact for more information?
Rebecca Turner, MS, CCRP
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2279
cancer@cchmc.org
