RATIONALE: Drugs used in chemotherapy, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.
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. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Childrens Oncology Group
Philadelphia, Pennsylvania, United States
Short Term Feasibility Success
Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure.
Time frame: 24 weeks
Long Term Feasibility Success
Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success.
Time frame: 60 weeks
Number of Participants Who Experienced Toxic Death
Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.
Time frame: Up to 6 years after the start of protocol therapy
Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.
Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.
Time frame: Up to 18 months of protocol therapy
Percent Probability of Progression-free Survival (PFS)
Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.
Time frame: 3 years
Percentage Probability of Event-free Survival (EFS)
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Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.
Time frame: Six years
Total Number of Patients Experiencing a Response
Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.
Time frame: Up to 18 months of protocol therapy