Trial · NCT00275002
O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors
NCT00275002, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors. Trials, record NCT00275002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00275002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- O6-Benzylguanine and Temozolomide in Treating Young Patients With Recurrent or Progressive Gliomas or Brain Stem Tumors
- NCT number
- NCT00275002
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- O6-benzylguanine, temozolomide
- First posted
- 2006-01-11
- Last updated
- 2022-02-11
- Results first posted
- 2011-08-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 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 | 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 treatment regimen is determined by the participant's attending physician at the enrolling institution and verified by the study chair. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Objective Response (Complete Response or Partial Response) | Week 8, 16, 24, 32, and 40 after starting therapy | Participants included in assessing objective response were those who completed two courses of therapy or those who died or experienced progressive disease prior to completing the second course. | Percent of Participants | NUMBER |
| SECONDARY | 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 | Participants who received at least one day of the treatment regimen were included in the analysis of this objective. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Objective Response (Complete Response or Partial Response) | Recurrent High-Grade Gliomas | 4 | 95% Confidence Interval 0.1 to 20 | Percent of Participants | |
| Percentage of Participants With an Objective Response (Complete Response or Partial Response) | Recurrent Brain Stem Tumors | 0 | 95% Confidence Interval 0 to 21 | Percent of Participants | |
| Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide | Recurrent High-Grade Gliomas | 16 | Participants | ||
| Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide | Recurrent Brain Stem Tumors | 10 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recurrent High-Grade Gliomas | 25 | |
| Overall Study | STARTED | Recurrent Brain Stem Tumors | 16 | |
| Overall Study | COMPLETED | Recurrent High-Grade Gliomas | 3 | |
| Overall Study | COMPLETED | Recurrent Brain Stem Tumors | 0 | |
| Overall Study | NOT COMPLETED | Recurrent High-Grade Gliomas | 22 | |
| Overall Study | NOT COMPLETED | Recurrent Brain Stem Tumors | 16 |
Source ClinicalTrials.gov
Adverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT,SGPT | Investigations | Recurrent High-Grade Gliomas | 6 | 25 | |
| other | ALT,SGPT | Investigations | Recurrent Brain Stem Tumors | 3 | 16 | |
| other | ALT,SGOT | Investigations | Recurrent High-Grade Gliomas | 3 | 25 | |
| other | ALT,SGOT | Investigations | Recurrent Brain Stem Tumors | 1 | 16 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Recurrent High-Grade Gliomas | 5 | 25 | |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Recurrent Brain Stem Tumors | 2 | 16 | |
| other | Alkaline phosphatase | Investigations | Recurrent High-Grade Gliomas | 2 | 25 | |
| other | Alkaline phosphatase | Investigations | Recurrent Brain Stem Tumors | 2 | 16 | |
| other | Anorexia | Metabolism and nutrition disorders | Recurrent High-Grade Gliomas | 3 | 25 | |
| other | Anorexia | Metabolism and nutrition disorders | Recurrent Brain Stem Tumors | 0 | 16 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recurrent High-Grade Gliomas | ||
| Total, all-cause mortality | Recurrent Brain Stem Tumors | ||
| Total, other adverse events | Recurrent High-Grade Gliomas | 25 | 25 |
| Total, other adverse events | Recurrent Brain Stem Tumors | 16 | 16 |
| Total, serious adverse events | Recurrent High-Grade Gliomas | 15 | 25 |
| Total, serious adverse events | Recurrent Brain Stem Tumors | 12 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Recurrent High-Grade Gliomas vs Recurrent Brain Stem Tumors: Number of Patients With Grade 3 or 4 Adverse Events at Least Possibly Related to the Combination of O6-benzylguanine and Temozolomide | Trial comparisons |
| Recurrent High-Grade Gliomas vs Recurrent Brain Stem Tumors: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00275002
GET https://conductscience.org/api/trials/v1/NCT00275002/events?page=2