A Phase II Trial of O6-Benzylguanine and Temozolomide in Pediatric Patients With Recurrent or Progressive High-Grade Gliomas and Recurrent or Progressive Brainstem Tumors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 41
- Locations
- 11
- Primary Endpoint
- Percentage of Participants With an Objective Response (Complete Response or Partial Response)
Study Overview
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 them from dividing. O6-benzylguanine may help temozolomide work better by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
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.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (high-grade gliomas vs brain stem tumors).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
O6-BG and TMZ
O6-benzylguanine (O6-BG) and temozolomide (TMZ)
Intervention: O6-benzylguanine (Drug)
O6-BG and TMZ
O6-benzylguanine (O6-BG) and temozolomide (TMZ)
Intervention: temozolomide (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With an Objective Response (Complete Response or Partial Response)
Time Frame: 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 response must be sustained for at least 8 weeks, and the date of the confirmed sustained response is the date at which the response was first noted by MRI.
Secondary Outcomes
- 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)