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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189266
Recruitment Status : Active, not recruiting
First Posted : August 26, 2010
Results First Posted : March 3, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Astrocytoma
Anaplastic Oligoastrocytoma
Brain Stem Glioma
Childhood Glioblastoma
Giant Cell Glioblastoma
Gliosarcoma
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Drug: Vorinostat
Enrollment 79
Recruitment Details Phase I /II study. Phase I determined Maximum Tolerated Dose between the first 2 treatment arms; zero patients completed therapy. Study was closed, then reopened to accrual. Phase II enrolled an additional 67 patients. Overall, 79 patients were enrolled but only 2 patients completed all 12 cycles of maintenance chemotherapy.
Pre-assignment Details  
Arm/Group Title Arm 1, Phase I Vorinostat 180 mg/m^2 Arm 2, Phase I Vorinostat 230 mg/m^2 Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 6 6 67
Completed 0 0 2
Not Completed 6 6 65
Reason Not Completed
Adverse Event             1             0             5
Death             0             0             5
Lack of Efficacy             4             5             44
Physician Decision             0             0             1
Protocol Violation             0             1             1
Withdrawal by Subject             0             0             1
Patient refuses further therapy             1             0             7
No treatment             0             0             1
Arm/Group Title Arm 1 Phase I Vorinostat 180 mg/m^2 Arm 2 Phase 1 Vorinostat 230 mg/m^2 Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2 Total
Hide Arm/Group Description

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 6 6 67 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 67 participants 79 participants
<=18 years
6
 100.0%
6
 100.0%
66
  98.5%
78
  98.7%
Between 18 and 65 years
0
   0.0%
0
   0.0%
1
   1.5%
1
   1.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 67 participants 79 participants
6
(4 to 16)
9
(4 to 11)
6
(3 to 19)
6
(3 to 19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 67 participants 79 participants
Female
4
  66.7%
4
  66.7%
36
  53.7%
44
  55.7%
Male
2
  33.3%
2
  33.3%
31
  46.3%
35
  44.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 67 participants 79 participants
Hispanic or Latino
1
  16.7%
0
   0.0%
15
  22.4%
16
  20.3%
Not Hispanic or Latino
5
  83.3%
5
  83.3%
51
  76.1%
61
  77.2%
Unknown or Not Reported
0
   0.0%
1
  16.7%
1
   1.5%
2
   2.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 67 participants 79 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
3
   4.5%
3
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
8
  11.9%
8
  10.1%
White
6
 100.0%
5
  83.3%
47
  70.1%
58
  73.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  16.7%
9
  13.4%
10
  12.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 67 participants 79 participants
United States 5 5 62 62
Australia 0 0 3 3
Canada 1 1 1 3
Puerto Rico 0 0 1 1
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Vorinostat
Hide Description The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy
Time Frame Planned 7 weeks during chemoradiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Phase 1 Study Participants
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: mg/m^2
230
2.Primary Outcome
Title Event-Free Survival
Hide Description Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.
Time Frame 2 years after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.
Arm/Group Title Arm 1, Phase I Vorinostat 180 mg/m^2 Arm 2, Phase I Vorinostat 230 mg/m^2 Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 6 6 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
0
(0 to 0)
0
(0 to 0)
3.1
(0.59 to 9.6)
3.Primary Outcome
Title Incidence of Toxicity During Chemoradiation Therapy
Hide Description Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
Time Frame Planned 7 weeks during chemoradiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1, Phase I Vorinostat 180 mg/m^2 Arm 2, Phase I Vorinostat 230 mg/m^2 Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 6 6 65
Measure Type: Count of Participants
Unit of Measure: Participants
5
  83.3%
2
  33.3%
24
  36.9%
4.Primary Outcome
Title Incidence of Toxicity During Maintenance Therapy
Hide Description Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience
Time Frame Planned 12 months of maintenance with Vorinostat
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1, Phase I Vorinostat 180 mg/m^2 Arm 2, Phase I Vorinostat 230 mg/m^2 Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 6 6 60
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
4
  66.7%
39
  65.0%
5.Secondary Outcome
Title Overall Survival
Hide Description Time from enrollment to death or last follow-up, whichever occurs first.
Time Frame 2 years after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
One patient enrolled on Arm 3 was withdrawn from study prior to the start of treatment.
Arm/Group Title Arm 1, Phase I Vorinostat 180 mg/m^2 Arm 2, Phase I Vorinostat 230 mg/m^2 Arm 3, Phase II Evaluation Vorinostat 230 mg/m^2
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 6 6 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
22
(0.96 to 61)
0
(0 to 0)
3.1
(0.58 to 9.5)
6.Secondary Outcome
Title Change in H3 and H4 Acetylation Levels in PBMCs
Hide Description Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.
Time Frame Baseline to up to 7 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Change in NHEJ Activity in PBMCs
Hide Description Descriptive statistics will be used to summarize the biological/laboratory measures and the changes in these measures across time-points.
Time Frame Baseline to up to 7 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Levels of DNA Repair Proteins in Paraffin-embedded Blocks, Measured Via Immunohistochemistry or Western Analysis
Hide Description 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.
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame Up to 2 years
Adverse Event Reporting Description 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). The “AE Other” table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
 
Arm/Group Title Arm 1 Phase I Vorinostat 180 mg/m^2 Arm 2 Phase 1 Vorinostat 230 mg/m^2 Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Arm 1 Phase I Vorinostat 180 mg/m^2 Arm 2 Phase 1 Vorinostat 230 mg/m^2 Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)      6/6 (100.00%)      62/65 (95.38%)    
Hide Serious Adverse Events
Arm 1 Phase I Vorinostat 180 mg/m^2 Arm 2 Phase 1 Vorinostat 230 mg/m^2 Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      5/6 (83.33%)      55/65 (84.62%)    
Blood and lymphatic system disorders       
Anemia   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Blood and lymphatic system disorders - Other, specify   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Febrile neutropenia   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Gastrointestinal disorders       
Abdominal pain   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Dysphagia   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Mucositis oral   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Nausea   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Vomiting   0/6 (0.00%)  0 1/6 (16.67%)  1 1/65 (1.54%)  1
General disorders       
Death NOS   3/6 (50.00%)  3 2/6 (33.33%)  2 34/65 (52.31%)  34
Fatigue   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Infusion related reaction   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Infections and infestations       
Catheter related infection   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Infections and infestations - Other, specify   1/6 (16.67%)  1 0/6 (0.00%)  0 1/65 (1.54%)  1
Lip infection   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Lung infection   1/6 (16.67%)  1 0/6 (0.00%)  0 1/65 (1.54%)  1
Sinusitis   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Skin infection   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Upper respiratory infection   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Urinary tract infection   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Investigations       
Creatinine increased   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Lymphocyte count decreased   0/6 (0.00%)  0 0/6 (0.00%)  0 6/65 (9.23%)  7
Neutrophil count decreased   0/6 (0.00%)  0 0/6 (0.00%)  0 9/65 (13.85%)  10
Platelet count decreased   0/6 (0.00%)  0 0/6 (0.00%)  0 9/65 (13.85%)  10
Weight loss   0/6 (0.00%)  0 0/6 (0.00%)  0 4/65 (6.15%)  4
White blood cell decreased   0/6 (0.00%)  0 0/6 (0.00%)  0 5/65 (7.69%)  5
Metabolism and nutrition disorders       
Anorexia   0/6 (0.00%)  0 0/6 (0.00%)  0 3/65 (4.62%)  3
Dehydration   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Glucose intolerance   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Hyperglycemia   0/6 (0.00%)  0 0/6 (0.00%)  0 3/65 (4.62%)  4
Hyperkalemia   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Hypermagnesemia   0/6 (0.00%)  0 1/6 (16.67%)  1 3/65 (4.62%)  3
Hypoalbuminemia   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Hypokalemia   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Hyponatremia   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders       
Muscle weakness right-sided   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify   0/6 (0.00%)  0 1/6 (16.67%)  1 11/65 (16.92%)  11
Nervous system disorders       
Depressed level of consciousness   0/6 (0.00%)  0 0/6 (0.00%)  0 3/65 (4.62%)  3
Dysarthria   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Headache   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Hydrocephalus   0/6 (0.00%)  0 1/6 (16.67%)  1 3/65 (4.62%)  3
Intracranial hemorrhage   0/6 (0.00%)  0 0/6 (0.00%)  0 3/65 (4.62%)  3
Reversible posterior leukoencephalopathy syndrome   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Seizure   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Somnolence   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Spasticity   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Psychiatric disorders       
Agitation   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Confusion   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Renal and urinary disorders       
Hematuria   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Urinary retention   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Aspiration   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Dyspnea   0/6 (0.00%)  0 0/6 (0.00%)  0 3/65 (4.62%)  3
Hypoxia   0/6 (0.00%)  0 0/6 (0.00%)  0 3/65 (4.62%)  3
Skin and subcutaneous tissue disorders       
Rash maculo-papular   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Skin and subcutaneous tissue disorders - Other, specify   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Urticaria   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Vascular disorders       
Hypertension   0/6 (0.00%)  0 1/6 (16.67%)  1 3/65 (4.62%)  3
Thromboembolic event   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Phase I Vorinostat 180 mg/m^2 Arm 2 Phase 1 Vorinostat 230 mg/m^2 Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      6/6 (100.00%)      51/65 (78.46%)    
Blood and lymphatic system disorders       
Anemia   6/6 (100.00%)  10 6/6 (100.00%)  8 3/65 (4.62%)  3
Cardiac disorders       
Chest pain - cardiac   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Mobitz type I   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Palpitations   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Sinus bradycardia   2/6 (33.33%)  2 0/6 (0.00%)  0 1/65 (1.54%)  1
Sinus tachycardia   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Ear and labyrinth disorders       
Ear pain   2/6 (33.33%)  2 1/6 (16.67%)  1 0/65 (0.00%)  0
Tinnitus   0/6 (0.00%)  0 2/6 (33.33%)  2 0/65 (0.00%)  0
Vertigo   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Endocrine disorders       
Adrenal insufficiency   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Cushingoid   2/6 (33.33%)  2 0/6 (0.00%)  0 0/65 (0.00%)  0
Eye disorders       
Blurred vision   1/6 (16.67%)  1 1/6 (16.67%)  1 2/65 (3.08%)  2
Conjunctivitis   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Extraocular muscle paresis   2/6 (33.33%)  2 1/6 (16.67%)  1 1/65 (1.54%)  1
Eye disorders - Other, specify   3/6 (50.00%)  3 4/6 (66.67%)  5 6/65 (9.23%)  6
Eyelid function disorder   0/6 (0.00%)  0 1/6 (16.67%)  1 1/65 (1.54%)  1
Photophobia   0/6 (0.00%)  0 1/6 (16.67%)  1 1/65 (1.54%)  1
Gastrointestinal disorders       
Abdominal distension   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Abdominal pain   2/6 (33.33%)  2 2/6 (33.33%)  2 1/65 (1.54%)  1
Anal pain   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Cheilitis   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Constipation   5/6 (83.33%)  5 5/6 (83.33%)  5 2/65 (3.08%)  2
Diarrhea   3/6 (50.00%)  3 2/6 (33.33%)  2 0/65 (0.00%)  0
Dry mouth   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Dyspepsia   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Dysphagia   3/6 (50.00%)  3 4/6 (66.67%)  4 3/65 (4.62%)  3
Esophageal pain   0/6 (0.00%)  0 2/6 (33.33%)  2 0/65 (0.00%)  0
Fecal incontinence   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Flatulence   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Gastroesophageal reflux disease   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Mucositis oral   3/6 (50.00%)  3 0/6 (0.00%)  0 1/65 (1.54%)  1
Nausea   4/6 (66.67%)  4 5/6 (83.33%)  6 5/65 (7.69%)  5
Oral hemorrhage   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Stomach pain   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Vomiting   5/6 (83.33%)  8 5/6 (83.33%)  7 6/65 (9.23%)  6
General disorders       
Chills   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Fatigue   5/6 (83.33%)  5 6/6 (100.00%)  8 9/65 (13.85%)  10
Fever   3/6 (50.00%)  3 0/6 (0.00%)  0 2/65 (3.08%)  2
Flu like symptoms   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Gait disturbance   1/6 (16.67%)  1 3/6 (50.00%)  3 5/65 (7.69%)  5
General disorders and administration site conditions - Other, specify   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Irritability   2/6 (33.33%)  4 1/6 (16.67%)  1 3/65 (4.62%)  3
Malaise   0/6 (0.00%)  0 1/6 (16.67%)  1 2/65 (3.08%)  2
Pain   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Immune system disorders       
Allergic reaction   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Infections and infestations       
Bladder infection   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Bronchial infection   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Conjunctivitis infective   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Infections and infestations - Other, specify   2/6 (33.33%)  2 1/6 (16.67%)  1 2/65 (3.08%)  2
Lip infection   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Mucosal infection   1/6 (16.67%)  1 2/6 (33.33%)  3 2/65 (3.08%)  2
Otitis media   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Sinusitis   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Skin infection   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Upper respiratory infection   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Wound infection   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Injury, poisoning and procedural complications       
Bruising   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Dermatitis radiation   2/6 (33.33%)  2 0/6 (0.00%)  0 0/65 (0.00%)  0
Injury, poisoning and procedural complications - Other, specify   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Investigations       
Alanine aminotransferase increased   6/6 (100.00%)  7 4/6 (66.67%)  4 3/65 (4.62%)  3
Alkaline phosphatase increased   2/6 (33.33%)  2 0/6 (0.00%)  0 1/65 (1.54%)  1
Aspartate aminotransferase increased   3/6 (50.00%)  3 1/6 (16.67%)  1 1/65 (1.54%)  1
Blood bilirubin increased   3/6 (50.00%)  5 2/6 (33.33%)  2 0/65 (0.00%)  0
Cholesterol high   1/6 (16.67%)  1 1/6 (16.67%)  1 2/65 (3.08%)  2
Creatinine increased   5/6 (83.33%)  5 2/6 (33.33%)  2 3/65 (4.62%)  3
GGT increased   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Investigations - Other, specify   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Lipase increased   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Lymphocyte count decreased   6/6 (100.00%)  15 5/6 (83.33%)  9 9/65 (13.85%)  9
Lymphocyte count increased   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Neutrophil count decreased   5/6 (83.33%)  8 4/6 (66.67%)  6 8/65 (12.31%)  9
Platelet count decreased   5/6 (83.33%)  10 5/6 (83.33%)  6 7/65 (10.77%)  7
Serum amylase increased   1/6 (16.67%)  2 0/6 (0.00%)  0 0/65 (0.00%)  0
Weight gain   2/6 (33.33%)  2 0/6 (0.00%)  0 1/65 (1.54%)  1
Weight loss   0/6 (0.00%)  0 2/6 (33.33%)  2 2/65 (3.08%)  2
White blood cell decreased   6/6 (100.00%)  12 4/6 (66.67%)  7 8/65 (12.31%)  9
Metabolism and nutrition disorders       
Anorexia   4/6 (66.67%)  4 4/6 (66.67%)  5 2/65 (3.08%)  2
Dehydration   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Hypercalcemia   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Hyperglycemia   4/6 (66.67%)  5 4/6 (66.67%)  6 6/65 (9.23%)  6
Hyperkalemia   0/6 (0.00%)  0 1/6 (16.67%)  1 1/65 (1.54%)  1
Hypermagnesemia   4/6 (66.67%)  4 6/6 (100.00%)  6 3/65 (4.62%)  3
Hypernatremia   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Hypertriglyceridemia   1/6 (16.67%)  2 0/6 (0.00%)  0 0/65 (0.00%)  0
Hypoalbuminemia   3/6 (50.00%)  4 1/6 (16.67%)  1 0/65 (0.00%)  0
Hypocalcemia   2/6 (33.33%)  2 2/6 (33.33%)  2 2/65 (3.08%)  2
Hypoglycemia   2/6 (33.33%)  3 0/6 (0.00%)  0 1/65 (1.54%)  1
Hypokalemia   5/6 (83.33%)  5 1/6 (16.67%)  1 4/65 (6.15%)  4
Hyponatremia   2/6 (33.33%)  2 3/6 (50.00%)  3 4/65 (6.15%)  4
Hypophosphatemia   3/6 (50.00%)  3 2/6 (33.33%)  2 1/65 (1.54%)  1
Metabolism and nutrition disorders - Other, specify   1/6 (16.67%)  2 2/6 (33.33%)  2 0/65 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Generalized muscle weakness   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Muscle weakness left-sided   3/6 (50.00%)  5 0/6 (0.00%)  0 1/65 (1.54%)  1
Muscle weakness lower limb   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Muscle weakness right-sided   2/6 (33.33%)  2 2/6 (33.33%)  2 6/65 (9.23%)  6
Muscle weakness upper limb   0/6 (0.00%)  0 1/6 (16.67%)  1 2/65 (3.08%)  2
Pain in extremity   0/6 (0.00%)  0 2/6 (33.33%)  2 0/65 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify   1/6 (16.67%)  1 3/6 (50.00%)  3 13/65 (20.00%)  13
Nervous system disorders       
Abducens nerve disorder   2/6 (33.33%)  2 2/6 (33.33%)  2 12/65 (18.46%)  12
Accessory nerve disorder   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Amnesia   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Ataxia   6/6 (100.00%)  6 6/6 (100.00%)  6 19/65 (29.23%)  19
Concentration impairment   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Dizziness   2/6 (33.33%)  2 0/6 (0.00%)  0 3/65 (4.62%)  3
Dysarthria   5/6 (83.33%)  6 1/6 (16.67%)  1 12/65 (18.46%)  13
Dysgeusia   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Dysphasia   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Extrapyramidal disorder   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Facial muscle weakness   0/6 (0.00%)  0 0/6 (0.00%)  0 5/65 (7.69%)  5
Facial nerve disorder   3/6 (50.00%)  3 3/6 (50.00%)  3 12/65 (18.46%)  12
Glossopharyngeal nerve disorder   1/6 (16.67%)  2 0/6 (0.00%)  0 3/65 (4.62%)  3
Headache   4/6 (66.67%)  4 5/6 (83.33%)  6 9/65 (13.85%)  9
Hydrocephalus   1/6 (16.67%)  1 0/6 (0.00%)  0 5/65 (7.69%)  6
Hypoglossal nerve disorder   2/6 (33.33%)  2 0/6 (0.00%)  0 2/65 (3.08%)  2
Intracranial hemorrhage   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Lethargy   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Nervous system disorders - Other, specify   1/6 (16.67%)  1 1/6 (16.67%)  2 5/65 (7.69%)  5
Nystagmus   1/6 (16.67%)  1 2/6 (33.33%)  2 3/65 (4.62%)  3
Paresthesia   1/6 (16.67%)  1 2/6 (33.33%)  2 0/65 (0.00%)  0
Peripheral motor neuropathy   1/6 (16.67%)  1 1/6 (16.67%)  1 1/65 (1.54%)  1
Peripheral sensory neuropathy   2/6 (33.33%)  2 0/6 (0.00%)  0 0/65 (0.00%)  0
Pyramidal tract syndrome   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Seizure   0/6 (0.00%)  0 0/6 (0.00%)  0 2/65 (3.08%)  2
Spasticity   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Tremor   1/6 (16.67%)  1 1/6 (16.67%)  1 0/65 (0.00%)  0
Trigeminal nerve disorder   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Vagus nerve disorder   1/6 (16.67%)  1 1/6 (16.67%)  2 1/65 (1.54%)  1
Psychiatric disorders       
Agitation   1/6 (16.67%)  1 1/6 (16.67%)  1 2/65 (3.08%)  3
Anxiety   1/6 (16.67%)  1 1/6 (16.67%)  1 1/65 (1.54%)  1
Confusion   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Depression   1/6 (16.67%)  1 2/6 (33.33%)  2 0/65 (0.00%)  0
Insomnia   1/6 (16.67%)  1 2/6 (33.33%)  3 1/65 (1.54%)  1
Personality change   0/6 (0.00%)  0 1/6 (16.67%)  1 1/65 (1.54%)  1
Psychiatric disorders - Other, specify   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Renal and urinary disorders       
Bladder spasm   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Hematuria   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Renal and urinary disorders - Other, specify   2/6 (33.33%)  2 1/6 (16.67%)  1 0/65 (0.00%)  0
Urinary incontinence   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Urinary retention   1/6 (16.67%)  1 2/6 (33.33%)  2 1/65 (1.54%)  1
Urinary tract pain   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Apnea   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Cough   4/6 (66.67%)  4 1/6 (16.67%)  1 0/65 (0.00%)  0
Dyspnea   2/6 (33.33%)  2 1/6 (16.67%)  1 0/65 (0.00%)  0
Epistaxis   2/6 (33.33%)  2 2/6 (33.33%)  2 0/65 (0.00%)  0
Hiccups   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Hypoxia   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Nasal congestion   2/6 (33.33%)  2 1/6 (16.67%)  1 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify   0/6 (0.00%)  0 1/6 (16.67%)  1 1/65 (1.54%)  1
Sneezing   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Sore throat   2/6 (33.33%)  2 1/6 (16.67%)  1 0/65 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia   2/6 (33.33%)  2 3/6 (50.00%)  3 0/65 (0.00%)  0
Hyperhidrosis   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Pruritus   2/6 (33.33%)  2 0/6 (0.00%)  0 0/65 (0.00%)  0
Rash acneiform   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Rash maculo-papular   3/6 (50.00%)  3 2/6 (33.33%)  2 1/65 (1.54%)  1
Skin and subcutaneous tissue disorders - Other, specify   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Skin hyperpigmentation   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Skin hypopigmentation   0/6 (0.00%)  0 1/6 (16.67%)  1 0/65 (0.00%)  0
Surgical and medical procedures       
Surgical and medical procedures - Other, specify   0/6 (0.00%)  0 0/6 (0.00%)  0 1/65 (1.54%)  1
Vascular disorders       
Hematoma   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Hot flashes   1/6 (16.67%)  1 0/6 (0.00%)  0 0/65 (0.00%)  0
Hypertension   5/6 (83.33%)  7 2/6 (33.33%)  3 2/65 (3.08%)  2
Hypotension   1/6 (16.67%)  1 0/6 (0.00%)  0 1/65 (1.54%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01189266    
Other Study ID Numbers: NCI-2011-02600
NCI-2011-02600 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACNS0927
S12-02793
COG-ACNS0927
CDR0000683459
ACNS0927 ( Other Identifier: Children's Oncology Group )
ACNS0927 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
UM1CA097452 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: July 5, 2019
Results First Posted: March 3, 2020
Last Update Posted: April 24, 2020