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Pilot Study of Carboplatin, Vincristine, and Temozolomide in Children With Progressive and/or Symptomatic Low-Grade Gliomas
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 | Protocol IDs |
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No phase specified | Treatment | Closed | 10 and under | COG-ACNS0223 ACNS0223, NCT00077207 |
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.
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 Surgery - See Disease Characteristics
- Prior surgery allowed
Other Patient Characteristics:
Age Performance status Life expectancy 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 50A total of 30-50 patients will be accrued for this study within 2 years. Outcomes Primary Outcome(s)Feasibility of delivering this chemotherapy regimen at 24 and 60 weeks
Secondary Outcome(s)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 ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | Murali Chintagumpala, MD, Protocol chair | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) |
Registry Information | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2004-07-06 | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00077207 | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2003-12-16 | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2007-08-02 | ![](https://webarchive.library.unt.edu/web/20090514165900im_/http://www.cancer.gov/images/spacer.gif) | NCI Grant/Contract Number | | CA98543 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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