Trial · NCT01189266

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

NCT01189266, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma. Trials, record NCT01189266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01189266

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
NCT number: NCT01189266
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 79 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Diffuse Intrinsic Pontine Glioma, Gliosarcoma
Interventions: 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Vorinostat
First posted: 2010-08-26
Last updated: 2021-10-28
Results first posted: 2020-03-03

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) of Vorinostat	Planned 7 weeks during chemoradiotherapy	The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy
Primary	Event-Free Survival	2 years after study enrollment	Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.
Primary	Incidence of Toxicity During Chemoradiation Therapy	Planned 7 weeks during chemoradiotherapy	Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
Primary	Incidence of Toxicity During Maintenance Therapy	Planned 12 months of maintenance with Vorinostat	Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
Secondary	Overall Survival	2 years after study enrollment	Time from enrollment to death or last follow-up, whichever occurs first.
Secondary	Change in H3 and H4 Acetylation Levels in PBMCs	Baseline to up to 7 weeks	Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.
Secondary	Change in NHEJ Activity in PBMCs	Baseline to up to 7 weeks	Descriptive statistics will be used to summarize the biological/laboratory measures and the changes in these measures across time-points.
Secondary	Levels of DNA Repair Proteins in Paraffin-embedded Blocks, Measured Via Immunohistochemistry or Western Analysis	Baseline	For immunohistochemistry from tumor blocks, the intensity will be graded from 1 to 3; for Western analysis, a percentage of the intensity relative to the tumor with the highest level will be measured.

Source ClinicalTrials.gov

Outcomes8

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	Planned 7 weeks during chemoradiotherapy	All patients enrolled on arm 1 and 2 who received at least 85% of the planned doses of radiation therapy and chemotherapy in the chemoradiotherapy portion of the study or who experienced DLT after after receiving at least one dose of chemoradio therapy and completing 7 weeks fo follow-up.	mg/m^2	NUMBER
PRIMARY	Event-Free Survival	2 years after study enrollment	One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.	percent probability	NUMBER
PRIMARY	Incidence of Toxicity During Chemoradiation Therapy	Planned 7 weeks during chemoradiotherapy	All patients enrolled on Arm 1 and 2 received at least one dose of chemoradiation therapy. Two patients enrolled on arm 3 did not receive protocol therapy prior to date of removal from protocol therapy.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Incidence of Toxicity During Maintenance Therapy	Planned 12 months of maintenance with Vorinostat	All patients enrolled on arm 1 and 2 received at least one dose of maintenance therapy. Seven patients enrolled on arm 3 did not receive maintenance therapy prior to date of removal from protocol therapy.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	2 years after study enrollment	One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.	percent probability	NUMBER
SECONDARY	Change in H3 and H4 Acetylation Levels in PBMCs	Baseline to up to 7 weeks	Due to budgetary issues the planned laboratory testing was not performed and no data were collected
SECONDARY	Change in NHEJ Activity in PBMCs	Baseline to up to 7 weeks	Due to budgetary issues the planned laboratory testing was not performed and no data were collected
SECONDARY	Levels of DNA Repair Proteins in Paraffin-embedded Blocks, Measured Via Immunohistochemistry or Western Analysis	Baseline	Due to budgetary issues the planned laboratory testing was not performed and no data were collected

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose (MTD) of Vorinostat	All Phase 1 Study Participants	230		mg/m^2
Event-Free Survival	Arm 1, Phase I Vorinostat 180 mg/m^2	0	95% Confidence Interval 0 to 0	percent probability
Event-Free Survival	Arm 2, Phase I Vorinostat 230 mg/m^2	0	95% Confidence Interval 0 to 0	percent probability
Event-Free Survival	Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2	3.1	95% Confidence Interval 0.59 to 9.6	percent probability
Incidence of Toxicity During Chemoradiation Therapy	Arm 1, Phase I Vorinostat 180 mg/m^2	5		Participants
Incidence of Toxicity During Chemoradiation Therapy	Arm 2, Phase I Vorinostat 230 mg/m^2	2		Participants
Incidence of Toxicity During Chemoradiation Therapy	Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2	24		Participants
Incidence of Toxicity During Maintenance Therapy	Arm 1, Phase I Vorinostat 180 mg/m^2	6		Participants
Incidence of Toxicity During Maintenance Therapy	Arm 2, Phase I Vorinostat 230 mg/m^2	4		Participants
Incidence of Toxicity During Maintenance Therapy	Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2	39		Participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1, Phase I Vorinostat 180 mg/m^2	6
Overall Study	STARTED	Arm 2, Phase I Vorinostat 230 mg/m^2	6
Overall Study	STARTED	Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2	67
Overall Study	COMPLETED	Arm 1, Phase I Vorinostat 180 mg/m^2	0
Overall Study	COMPLETED	Arm 2, Phase I Vorinostat 230 mg/m^2	0
Overall Study	COMPLETED	Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2	2
Overall Study	NOT COMPLETED	Arm 1, Phase I Vorinostat 180 mg/m^2	6
Overall Study	NOT COMPLETED	Arm 2, Phase I Vorinostat 230 mg/m^2	6
Overall Study	NOT COMPLETED	Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2	65

Source ClinicalTrials.gov

Adverse events666

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	Arm 1 Phase I Vorinostat 180 mg/m^2	6	6	10
other	Anemia	Blood and lymphatic system disorders	Arm 2 Phase 1 Vorinostat 230 mg/m^2	6	6	8
other	Anemia	Blood and lymphatic system disorders	Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2	3	65	3
other	Chest pain - cardiac	Cardiac disorders	Arm 1 Phase I Vorinostat 180 mg/m^2	0	6	0
other	Chest pain - cardiac	Cardiac disorders	Arm 2 Phase 1 Vorinostat 230 mg/m^2	1	6	1
other	Chest pain - cardiac	Cardiac disorders	Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2	0	65	0
other	Mobitz type I	Cardiac disorders	Arm 1 Phase I Vorinostat 180 mg/m^2	0	6	0
other	Mobitz type I	Cardiac disorders	Arm 2 Phase 1 Vorinostat 230 mg/m^2	1	6	1
other	Mobitz type I	Cardiac disorders	Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2	0	65	0
other	Palpitations	Cardiac disorders	Arm 1 Phase I Vorinostat 180 mg/m^2	0	6	0

1 to 10 of 666Source ClinicalTrials.gov

See all 666 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1 Phase I Vorinostat 180 mg/m^2	4	6
Total, all-cause mortality	Arm 2 Phase 1 Vorinostat 230 mg/m^2	6	6
Total, all-cause mortality	Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2	62	65
Total, other adverse events	Arm 1 Phase I Vorinostat 180 mg/m^2	6	6
Total, other adverse events	Arm 2 Phase 1 Vorinostat 230 mg/m^2	6	6
Total, other adverse events	Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2	51	65
Total, serious adverse events	Arm 1 Phase I Vorinostat 180 mg/m^2	6	6
Total, serious adverse events	Arm 2 Phase 1 Vorinostat 230 mg/m^2	5	6
Total, serious adverse events	Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2	55	65

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants3

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
UM1CA097452	Pediatric Phase 1/Pilot Consortium	WEIGEL, BRENDA J.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2009 to 2018	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01189266

GET https://conductscience.org/api/trials/v1/NCT01189266/events?page=2

API reference For AI assistants