O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: O6-benzylguanine; Drug: temozolomide

• Registration Number: NCT00275002
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This phase II trial is studying how well giving O6-benzylguanine together with temozolomide works in treating young patients with recurrent or progressive gliomas or brain stem tumors. Drugs used in chemotherapy, such as O6-benzylguanine and temozolomide , work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping th...

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the sustained objective response rate to the combination of O6-benzylguanine and temozolomide in pediatric patients with recurrent or progressive high-grade gliomas and brain stem tumors.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Study Start: 2006-02
• Primary Completion: 2010-12-01
• Study Completion: 2010-12
• Results First Submitted: 2011-07-13
• Results First Submitted QC: 2011-07-13
• Results First Posted: 2011-08-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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
O6-BG and TMZ	temozolomide	O6-benzylguanine (O6-BG) and temozolomide (TMZ)
O6-BG and TMZ	O6-benzylguanine	O6-benzylguanine (O6-BG) and temozolomide (TMZ)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Objective Response (Complete Response or Partial Response)	Week 8, 16, 24, 32, and 40 after starting therapy	The primary endpoint is to assess the percentage of participants with a sustained objective response (complete response (CR) or partial response (PR)). Response is assessed by magnetic resonance imaging (MRI) per the following criteria: CR - disappearance of tumor and PR - ≥50% reduction in tumor based on the maximal cross-sectional measurements. The respons...

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide	From day 1 of therapy up to 49 months	Clinical and laboratory studies to assess adverse events are obtained at least every four weeks (prior to each course) with some laboratory studies obtained every 2 weeks. Adverse events are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Attribution of each adverse event to the treat...

Trial Locations

Locations (11)

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Children's Memorial Hospital - Chicago; 🇺🇸 Chicago, Illinois, United States

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Dan L. Duncan Cancer Center at Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Children's Hospital and Regional Medical Center - Seattle; 🇺🇸 Seattle, Washington, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States