Trial · NCT01236560
Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
NCT01236560, Phase 2, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2020-06-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma. Trials, record NCT01236560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01236560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
- NCT number
- NCT01236560
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 101 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Brain Stem Glioma, Cerebral Astrocytoma, Childhood Cerebellar Anaplastic Astrocytoma, Childhood Cerebral Anaplastic Astrocytoma, Childhood Spinal Cord Neoplasm
- Interventions
- Bevacizumab, Temozolomide, Vorinostat
- First posted
- 2010-11-08
- Last updated
- 2024-02-20
- Results first posted
- 2020-06-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Vorinostat | 10 weeks | The dose of vorinostat in mg/sq m/day to be administered with combination chemotherapy and radiation therapy. |
| Primary | Event-free Survival | 1 year after enrollment | Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first. Disease progression is evaluated according to the COG criteria for measurement of brain tumors and is defined to be a ≥ 25% increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed since the start of treatment; OR the appearance of one or more new lesions, OR worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) PLUS any increase in tumor cross-sectional area (or tumor volume). |
| Secondary | Overall Survival | 1 year after enrollment | Time from enrollment to death or last follow-up, whichever occurs first. |
| Secondary | Cumulative Incidence of Disease Progression in Each Treatment Arm | 1 year after enrollment | Cumulative incidence of progression where death from any cause prior to progression and diagnosis of a second malignant neoplasm prior to progression are considered competing events. Disease progression is evaluated according to the COG criteria for measurement of brain tumors and is defined to be a ≥ 25% increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed since the start of treatment; OR the appearance of one or more new lesions, OR worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) PLUS any increase in tumor cross-sectional area (or tumor volume). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Vorinostat | 10 weeks | MTD is determined using only patients treated with vorinostat | mg/sq m | NUMBER |
| PRIMARY | Event-free Survival | 1 year after enrollment | Only eligible patients included in analysis | percent probability | NUMBER |
| SECONDARY | Overall Survival | 1 year after enrollment | Only eligible patients included in analysis | percent probability | NUMBER |
| SECONDARY | Cumulative Incidence of Disease Progression in Each Treatment Arm | 1 year after enrollment | Only eligible patients included in analysis. | percent probability | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Vorinostat | Feasibility (Vorinostat) | 230 | mg/sq m | ||
| Event-free Survival | Feasibility (Vorinostat) | 33.3 | 95% Confidence Interval 26.6 to 68 | percent probability | |
| Event-free Survival | Arm I (Vorinostat, Phase II Arm A) | 41.3 | 95% Confidence Interval 23.7 to 58.3 | percent probability | |
| Event-free Survival | Arm II (Temozolomide, Phase II Arm B) | 59.3 | 95% Confidence Interval 38.6 to 75.0 | percent probability | |
| Event-free Survival | Arm III (Bevacizumab, Phase II Arm C) | 43.8 | 95% Confidence Interval 26.5 to 59.8 | percent probability | |
| Overall Survival | Feasibility (Vorinostat) | 33.3 | 95% Confidence Interval 2.6 to 68 | percent probability | |
| Overall Survival | Arm I (Vorinostat, Phase II Arm A) | 82.2 | 95% Confidence Interval 62.5 to 92.2 | percent probability | |
| Overall Survival | Arm II (Temozolomide, Phase II Arm B) | 85.2 | 95% Confidence Interval 65.2 to 94.2 | percent probability | |
| Overall Survival | Arm III (Bevacizumab, Phase II Arm C) | 67.3 | 95% Confidence Interval 47.7 to 80.9 | percent probability | |
| Cumulative Incidence of Disease Progression in Each Treatment Arm | Feasibility (Vorinostat) | 67 | 95% Confidence Interval 22 to 100 | percent probability |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Feasibility (Vorinostat) | 6 | |
| Overall Study | STARTED | Arm I (Vorinostat, Phase II Arm A) | 32 | |
| Overall Study | STARTED | Arm II (Temozolomide, Phase II Arm B) | 31 | |
| Overall Study | STARTED | Arm III (Bevacizumab, Phase II Arm C) | 32 | |
| Overall Study | STARTED | Arm IV (Temozolomide, Phase III Arm B) | 0 | |
| Overall Study | STARTED | Arm V (Vorinostat/Bevacizumab, Phase III, Chemoradiotherapy | 0 | |
| Overall Study | COMPLETED | Feasibility (Vorinostat) | 1 | |
| Overall Study | COMPLETED | Arm I (Vorinostat, Phase II Arm A) | 8 | |
| Overall Study | COMPLETED | Arm II (Temozolomide, Phase II Arm B) | 11 | |
| Overall Study | COMPLETED | Arm III (Bevacizumab, Phase II Arm C) | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events304
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 | Anemia | Blood and lymphatic system disorders | Feasibility (Vorinostat) | 0 | 6 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Vorinostat, Phase II Arm A) | 2 | 29 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Temozolomide, Phase II Arm B) | 1 | 27 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Arm III (Bevacizumab, Phase II Arm C) | 2 | 32 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Feasibility (Vorinostat) | 0 | 6 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (Vorinostat, Phase II Arm A) | 2 | 29 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (Temozolomide, Phase II Arm B) | 2 | 27 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III (Bevacizumab, Phase II Arm C) | 1 | 32 | 1 |
| other | Eye disorders - Other, specify | Eye disorders | Feasibility (Vorinostat) | 0 | 6 | 0 |
| other | Eye disorders - Other, specify | Eye disorders | Arm I (Vorinostat, Phase II Arm A) | 0 | 29 | 0 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Feasibility (Vorinostat) | 5 | 6 |
| Total, all-cause mortality | Arm I (Vorinostat, Phase II Arm A) | 24 | 29 |
| Total, all-cause mortality | Arm II (Temozolomide, Phase II Arm B) | 22 | 27 |
| Total, all-cause mortality | Arm III (Bevacizumab, Phase II Arm C) | 23 | 32 |
| Total, other adverse events | Feasibility (Vorinostat) | 2 | 6 |
| Total, other adverse events | Arm I (Vorinostat, Phase II Arm A) | 13 | 29 |
| Total, other adverse events | Arm II (Temozolomide, Phase II Arm B) | 14 | 27 |
| Total, other adverse events | Arm III (Bevacizumab, Phase II Arm C) | 16 | 32 |
| Total, serious adverse events | Feasibility (Vorinostat) | 4 | 6 |
| Total, serious adverse events | Arm I (Vorinostat, Phase II Arm A) | 9 | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 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/NCT01236560
GET https://conductscience.org/api/trials/v1/NCT01236560/events?page=2