Trial · NCT00619112
Temozolomide in Treating Patients With Recurrent High-Grade Glioma
NCT00619112, Phase 2, Completed, University of California, San Francisco; results first posted 2013-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Temozolomide in Treating Patients With Recurrent High-Grade Glioma. Trials, record NCT00619112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00619112
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide in Treating Patients With Recurrent High-Grade Glioma
- NCT number
- NCT00619112
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Recurrent Central Nervous System Neoplasm
- Interventions
- temozolomide
- First posted
- 2008-02-20
- Last updated
- 2018-01-31
- Results first posted
- 2013-10-29
- Limitations and caveats
- The trial reached enrollment. There were no unexpected toxicities.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 Month Progression-free Survival | First day of treatment until progression or until 6 months mark | Efficacy of dose-intense temozolomide treatment schedule, as measured by 6 months progression-free survival |
| Secondary | Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. | First day of treatment until progression or until 6 months mark | Progression-free survival data (obtained for Primary Outcome Measure) was correlated with tumor MGMT (O(6)-methylguanine-DNA methyltransferase) promoter methylation status, obtained from patients as part of the study. |
| Secondary | Overall Survival | up to 2 years after treatment | |
| Secondary | Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System | prior to start of study | PCR analysis of tumor tissue for microsatellite instability (MSI). Tissue was obtained during surgeries prior this study. |
| Secondary | Patients Progressing After Two First-line Adjuvant Courses of Temozolomide | After two first-line adjuvant courses of temozolomide | |
| Secondary | Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide | Within 6 months after 6th adjuvant course of temozolomide | |
| Secondary | Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued | From beginning of voluntarily temozolomide discontinued up to 6 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6 Month Progression-free Survival | First day of treatment until progression or until 6 months mark | percentage of patients | NUMBER | |
| SECONDARY | Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. | First day of treatment until progression or until 6 months mark | Tumor tissue was available for the exploratory MGMT methylation analysis in 48 patients. In 7 samples the tissue was inadequate for analysis. | weeks | MEDIAN |
| SECONDARY | Overall Survival | up to 2 years after treatment | weeks | MEDIAN | |
| SECONDARY | Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System | prior to start of study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patients Progressing After Two First-line Adjuvant Courses of Temozolomide | After two first-line adjuvant courses of temozolomide | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide | Within 6 months after 6th adjuvant course of temozolomide | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued | From beginning of voluntarily temozolomide discontinued up to 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6 Month Progression-free Survival | Glioblastoma | 10 | 95% Confidence Interval 3 to 24 | percentage of patients | |
| 6 Month Progression-free Survival | Grade III Glioma | 50 | 95% Confidence Interval 27 to 73 | percentage of patients | |
| Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. | Glioblastoma With Methylated MGMT | 8.14 | 95% Confidence Interval 7.71 to NA | weeks | |
| Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. | Glioblastoma With Unmethylated MGMT | 7.57 | 95% Confidence Interval 7.29 to 9 | weeks | |
| Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. | Grade III Glioma With Methylated MGMT | 38.1 | 95% Confidence Interval 10.71 to NA | weeks | |
| Progression-free Survival (PFS) Based on Tumor MGMT (O(6)-Methylguanine-DNA Methyltransferase) Promoter Methylation Status. | Grade III Glioma With Unmethylated MGMT | 48.6 | 95% Confidence Interval 6.86 to NA | weeks | |
| Overall Survival | Glioblastoma | 21.6 | 95% Confidence Interval 16.9 to 30.6 | weeks | |
| Overall Survival | Grade III Glioma | 100.6 | 95% Confidence Interval 67 to NA | weeks | |
| Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System | Glioblastoma | 0 | Participants | ||
| Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System | Grade III Glioma | 0 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glioblastoma | 40 | |
| Overall Study | STARTED | Grade III Glioma | 20 | |
| Overall Study | COMPLETED | Glioblastoma | 39 | |
| Overall Study | COMPLETED | Grade III Glioma | 18 | |
| Overall Study | NOT COMPLETED | Glioblastoma | 1 | |
| Overall Study | NOT COMPLETED | Grade III Glioma | 2 |
Source ClinicalTrials.gov
Adverse events20
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 | Lymphocyte count decreased | Investigations | Temozolomide | 28 | 60 | |
| other | White blood cell decreased | Investigations | Temozolomide | 7 | 60 | |
| other | Neutrophil count decreased | Investigations | Temozolomide | 4 | 60 | |
| other | Platelet count decreased | Investigations | Temozolomide | 4 | 60 | |
| other | Peripheral motor neuropathy | Nervous system disorders | Temozolomide | 6 | 60 | |
| other | Depressed level of consciousness | Nervous system disorders | Temozolomide | 3 | 60 | |
| other | Seizure | Nervous system disorders | Temozolomide | 2 | 60 | |
| other | Dysphasia | Nervous system disorders | Temozolomide | 2 | 60 | |
| other | Confusion | Psychiatric disorders | Temozolomide | 1 | 60 | |
| other | Nervous system disorders - Other, specify | Nervous system disorders | Temozolomide | 1 | 60 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Temozolomide | 0 | 60 |
| Total, other adverse events | Temozolomide | 38 | 60 |
| Total, serious adverse events | Temozolomide | 0 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24670608 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Glioblastoma vs Grade III Glioma: Patients With Tumors With Functional Alterations of the Mismatch Repair (MMR) System | Trial comparisons |
| Glioblastoma vs Grade III Glioma: Patients Progressing 6 Months After Temozolomide is Voluntarily Discontinued | Trial comparisons |
| Glioblastoma vs Grade III Glioma: Patients Progressing Within 6 Months After 6th Adjuvant Course of Temozolomide | Trial comparisons |
| Glioblastoma vs Grade III Glioma: Patients Progressing After Two First-line Adjuvant Courses of Temozolomide | 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/NCT00619112
GET https://conductscience.org/api/trials/v1/NCT00619112/registered