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

Primary Purpose

Brain Tumor, Central Nervous System Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
carboplatin
temozolomide
vincristine sulfate
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring untreated childhood cerebellar astrocytoma, untreated childhood visual pathway and hypothalamic glioma, childhood spinal cord neoplasm, childhood oligodendroglioma, childhood low-grade cerebral astrocytoma

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

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 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/mm^3 Platelet count ≥ 100,000/mm^3 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 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

Sites / Locations

  • Childrens Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (carboplatin, vincristine sulfate, temozolomide)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Percent Probability of Progression-free Survival (PFS)
Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.
Percentage Probability of Event-free Survival (EFS)
Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.
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.

Full Information

First Posted
February 10, 2004
Last Updated
April 16, 2018
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077207
Brief Title
Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
Official Title
A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Central Nervous System Tumor
Keywords
untreated childhood cerebellar astrocytoma, untreated childhood visual pathway and hypothalamic glioma, childhood spinal cord neoplasm, childhood oligodendroglioma, childhood low-grade cerebral astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (carboplatin, vincristine sulfate, temozolomide)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Paraplatin, NSC #241240
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
Temodar, NSC# 362856
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Other Intervention Name(s)
Oncovin, VCR, LCR, NSC #67574
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Short Term Feasibility Success
Description
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
Title
Long Term Feasibility Success
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced Toxic Death
Description
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
Title
Number of Participants Who Experienced a Grade 3 or 4 Thrombocytopenia and/or Neutropenia.
Description
Occurence of grade 3 or 4 thrombocytopenia or neutropenia while receiving protocol therapy.
Time Frame
Up to 18 months of protocol therapy
Title
Percent Probability of Progression-free Survival (PFS)
Description
Percentage probability of being alive and without the occurrence of disease progression 3 years following enrollment.
Time Frame
3 years
Title
Percentage Probability of Event-free Survival (EFS)
Description
Percentage probability of being alive and without the occurrence of disease progression or second malignant neoplasm 6 years following enrollment.
Time Frame
Six years
Title
Total Number of Patients Experiencing a Response
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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 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/mm^3 Platelet count ≥ 100,000/mm^3 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murali M. Chintagumpala, MD
Organizational Affiliation
Texas Children's Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Childrens Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25854526
Citation
Chintagumpala M, Eckel SP, Krailo M, Morris M, Adesina A, Packer R, Lau C, Gajjar A. A pilot study using carboplatin, vincristine, and temozolomide in children with progressive/symptomatic low-grade glioma: a Children's Oncology Group studydagger. Neuro Oncol. 2015 Aug;17(8):1132-8. doi: 10.1093/neuonc/nov057. Epub 2015 Apr 7.
Results Reference
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Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma

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