TriangleNCT01189266 · STUDY IN CONTEXT
Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy
Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.
Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
Time from enrollment to death or last follow-up, whichever occurs first.
Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- trial label
- Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0000
- source section id
- NCT01189266-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD) of Vorinostat
- endpoint definition
- The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy
- time origin
- Planned 7 weeks during chemoradiotherapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0001
- source section id
- NCT01189266-om-0001
- source outcome index
- 1
- endpoint
- Event-Free Survival
- endpoint definition
- Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.
- time origin
- 2 years after study enrollment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0002
- source section id
- NCT01189266-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Toxicity During Chemoradiation Therapy
- endpoint definition
- Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
- time origin
- Planned 7 weeks during chemoradiotherapy
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0003
- source section id
- NCT01189266-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Toxicity During Maintenance Therapy
- endpoint definition
- Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
- time origin
- Planned 12 months of maintenance with Vorinostat
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0004
- source section id
- NCT01189266-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival
- endpoint definition
- Time from enrollment to death or last follow-up, whichever occurs first.
- time origin
- 2 years after study enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0005
- source section id
- NCT01189266-om-0005
- source outcome index
- 5
- endpoint
- Change in H3 and H4 Acetylation Levels in PBMCs
- endpoint definition
- Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.
- time origin
- Baseline to up to 7 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Due to budgetary issues the planned laboratory testing was not performed and no data were collected
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Phase 1 Study Participants
- regimen
- Arm 1, Phase 1 participants received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Arm 2, Phase 1 participants received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks).
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm 1, Phase I Vorinostat 180 mg/m^2
- regimen
- Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm 2, Phase I Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 66
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm 1, Phase I Vorinostat 180 mg/m^2
- regimen
- Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm 2, Phase I Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm 1, Phase I Vorinostat 180 mg/m^2
- regimen
- Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm 2, Phase I Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 60
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm 1, Phase I Vorinostat 180 mg/m^2
- regimen
- Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm 2, Phase I Vorinostat 230 mg/m^2
- regimen
- Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. 3-Dimensional Conformal Radiation Therapy: Undergo 3D conformal radiation therapy Intensity-Modulated Radiation Therapy: Undergo intensity-modulated radiation therapy Laboratory Biomarker Analysis: Correlative studies Vorinostat: Given PO
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01189266-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- harm key
- EG000
- source section id
- NCT01189266-ae
- event group key
- EG000
- event group label
- Arm 1 Phase I Vorinostat 180 mg/m^2
- serious affected
- 6
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 2 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- harm key
- EG001
- source section id
- NCT01189266-ae
- event group key
- EG001
- event group label
- Arm 2 Phase 1 Vorinostat 230 mg/m^2
- serious affected
- 5
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Up to 2 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-gliosarcoma
- nct id
- NCT01189266
- harm key
- EG002
- source section id
- NCT01189266-ae
- event group key
- EG002
- event group label
- Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
- serious affected
- 55
- serious at risk
- 65
- other affected
- 51
- other at risk
- 65
- frequency threshold
- 0
- collection period
- Up to 2 years
- event definition
- Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice