Trial · NCT00731731
Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00731731, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme. Trials, record NCT00731731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00731731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- NCT number
- NCT00731731
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
- Interventions
- 3-Dimensional Conformal Radiation Therapy, Cognitive Assessment, Laboratory Biomarker Analysis, Temozolomide, Vorinostat
- First posted
- 2008-08-11
- Last updated
- 2022-08-04
- Results first posted
- 2015-05-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I) | 10 weeks | The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. \> \> DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs: * Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting \> 7 days * Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism * Grade 4 radiation-induced skin changes * Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs |
| Primary | Overall Survival at 15 Months (Phase II) | Time from study registration to the date of death from any cause, assessed up to 5 years | The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date. |
| Secondary | Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade | Up to 5 years | Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given. |
| Secondary | Time to Tumor Progression (Phase II) | Up to 5 years | Progression free survival time will be defined from date of registration to date of progression or death. |
| Secondary | Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II) | Up to 5 years | The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I) | 10 weeks | number of patients with DLT | NUMBER | |
| PRIMARY | Overall Survival at 15 Months (Phase II) | Time from study registration to the date of death from any cause, assessed up to 5 years | percentage of phase II patients | NUMBER | |
| SECONDARY | Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade | Up to 5 years | participants evaluable for toxicity | NUMBER | |
| SECONDARY | Time to Tumor Progression (Phase II) | Up to 5 years | months | MEDIAN | |
| SECONDARY | Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II) | Up to 5 years | participants evaluable for toxicity | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I) | Phase I, Dose Level 0 | 3 | number of patients with DLT | ||
Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I) | Phase I, Dose Level 1 | 3 | number of patients with DLT | ||
| Overall Survival at 15 Months (Phase II) | Phase II | 54.6 | 95% Confidence Interval 45.9 to 65.0 | percentage of phase II patients | |
| Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade | Phase I, Dose Level 0 | 12 | participants evaluable for toxicity | ||
| Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade | Phase I, Dose Level 1 | 3 | participants evaluable for toxicity | ||
| Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade | Phase II | 107 | participants evaluable for toxicity | ||
| Time to Tumor Progression (Phase II) | Phase II | 8.05 | 95% Confidence Interval 6.21 to 9.30 | months | |
| Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II) | Phase I, Dose Level 0 | 12 | participants evaluable for toxicity | ||
| Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II) | Phase I, Dose Level 1 | 3 | participants evaluable for toxicity | ||
| Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II) | Phase II | 107 | participants evaluable for toxicity |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I, Dose Level 0 | 12 | |
| Overall Study | STARTED | Phase I, Dose Level 1 | 3 | |
| Overall Study | STARTED | Phase II | 110 | |
| Overall Study | COMPLETED | Phase I, Dose Level 0 | 12 | |
| Overall Study | COMPLETED | Phase I, Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Phase II | 107 | |
| Overall Study | NOT COMPLETED | Phase I, Dose Level 0 | 0 | |
| Overall Study | NOT COMPLETED | Phase I, Dose Level 1 | 0 | |
| Overall Study | NOT COMPLETED | Phase II | 3 |
Source ClinicalTrials.gov
Adverse events657
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 | Blood disorder | Blood and lymphatic system disorders | Phase I, Dose Level 0 | 0 | 12 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Phase I, Dose Level 1 | 0 | 3 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Phase II | 1 | 107 | 4 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I, Dose Level 0 | 9 | 12 | 28 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I, Dose Level 1 | 1 | 3 | 1 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II | 91 | 107 | 704 |
| other | Ear disorder | Ear and labyrinth disorders | Phase I, Dose Level 0 | 0 | 12 | 0 |
| other | Ear disorder | Ear and labyrinth disorders | Phase I, Dose Level 1 | 0 | 3 | 0 |
| other | Ear disorder | Ear and labyrinth disorders | Phase II | 3 | 107 | 7 |
| other | External ear pain | Ear and labyrinth disorders | Phase I, Dose Level 0 | 0 | 12 | 0 |
1 to 10 of 657Source ClinicalTrials.gov
See all 657 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I, Dose Level 0 | ||
| Total, all-cause mortality | Phase I, Dose Level 1 | ||
| Total, all-cause mortality | Phase II | ||
| Total, other adverse events | Phase I, Dose Level 0 | 12 | 12 |
| Total, other adverse events | Phase I, Dose Level 1 | 3 | 3 |
| Total, other adverse events | Phase II | 106 | 107 |
| Total, serious adverse events | Phase I, Dose Level 0 | 11 | 12 |
| Total, serious adverse events | Phase I, Dose Level 1 | 1 | 3 |
| Total, serious adverse events | Phase II | 63 | 107 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31386061 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA025224 | North Central Cancer Treatment Group | BUCKNER, JAN C | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00731731
GET https://conductscience.org/api/trials/v1/NCT00731731/events?page=2