Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

Phase 1

Completed

• Conditions: Central Nervous System Tumors; Brain Tumors
• Interventions: Drug: etoposide; Drug: vincristine sulfate; Radiation: radiation therapy

• Registration Number: NCT00003935
• Lead Sponsor: Children's Oncology Group

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.

Detailed Description

OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma. II. Assess the toxicity of this regimen in this patient population.

OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 1999-11-01
• Primary Completion: 2003-10
• Study First Submitted QC: 2004-02-19
• Study First Posted: 2004-02-20
• Study Completion: 2007-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	vincristine sulfate	Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
Treatment	radiation therapy	Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
Treatment	etoposide	Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter

Primary Outcome Measures

Name	Time	Method
Survival	1 year

Secondary Outcome Measures

Name	Time	Method
Monitor the toxicity

Trial Locations

Locations (110)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

Lucile Packard Children's Hospital at Stanford; 🇺🇸 Palo Alto, California, United States

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Kaiser Permanente-Southern California Permanente Medical Group; 🇺🇸 San Diego, California, United States

Children's Hospital and Health Center; 🇺🇸 San Diego, California, United States

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