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

Not Applicable

Completed

• Conditions: Brain Tumor; Central Nervous System Tumor
• Interventions: Drug: carboplatin; Drug: temozolomide; Drug: vincristine sulfate

• Registration Number: NCT00077207
• Lead Sponsor: Children's Oncology Group

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-10
• Study First Posted: 2004-02-11
• Study Start: 2004-07
• Primary Completion: 2010-03
• Study Completion: 2013-12
• Results First Submitted: 2014-01-08
• Results First Submitted QC: 2014-06-30
• Results First Posted: 2014-07-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (carboplatin, vincristine sulfate, temozolomide)	vincristine sulfate	Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) 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 (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
Treatment (carboplatin, vincristine sulfate, temozolomide)	temozolomide	Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) 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 (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
Treatment (carboplatin, vincristine sulfate, temozolomide)	carboplatin	Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) 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 (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.

Primary Outcome Measures

Name	Time	Method
Short Term Feasibility Success	24 weeks	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.
Long Term Feasibility Success	60 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Toxic Death	Up to 6 years after the start of protocol therapy	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.
Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.	Up to 18 months of protocol therapy	Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.
Total Number of Patients Experiencing a Response	Up to 18 months of protocol therapy	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.
Percent Probability of Progression-free Survival (PFS)	3 years	Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.
Percentage Probability of Event-free Survival (EFS)	Six years	Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.

Trial Locations

Locations (1)

Childrens Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States