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Efficacy of Hypofractionated XRT w/Bev. + Temozolomide for Recurrent Gliomas

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: NCT01478321
Recruitment Status : Terminated (Slow accrual to some cohorts)
First Posted : November 23, 2011
Results First Posted : March 12, 2020
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Interventions Drug: Temozolomide
Radiation: hypofractionated radiation therapy
Biological: bevacizumab
Other: questionnaire administration
Enrollment 54
Recruitment Details The study opened for accrual on November 14, 2011 with an accrual goal of up to 77 patients and the first patient being enrolled on December 14, 2011. The study was closed permanently on March 24, 2017 due to low accrual with 54 patients treated on the study.
Pre-assignment Details  
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Period Title: Concurrent Therapy (5 Weeks)
Started 54
Completed 38
Not Completed 16
Reason Not Completed
Adverse Event             4
Death             2
Withdrawal by Subject             5
Progressive Disease             5
Period Title: Started Adjuvant Therapy
Started 38
Completed First Cycle 37
Completed 37
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: Adjuvant Therapy Until PD or Toxicity
Started 37
Went on to Cycle 2 + 27
Completed 27
Not Completed 10
Reason Not Completed
Death             1
Withdrawal by Subject             1
Progressive Disease             8
Period Title: Follow-up Until Death or 12.31.18 Occurs
Started [1] 54
Completed 54
Not Completed 0
[1]
All patients that receive one dose of study treatment go into the follow up portion of the study.
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
0
   0.0%
Between 18 and 65 years
46
  85.2%
>=65 years
8
  14.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
17
  31.5%
Male
37
  68.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Hispanic or Latino
6
  11.1%
Not Hispanic or Latino
48
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.9%
Black or African American
3
   5.6%
White
48
  88.9%
More than one race
2
   3.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
 100.0%
Bevacizumab-Naive Recurrent GBM  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
8
  14.8%
Bevacizumab-Exposed Recurrent GBM  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
36
  66.7%
Bevacizumab-Naive Recurrent Anaplastic Glioma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
3
   5.6%
Bevacizumab-Exposed Recurrent Anaplastic Glioma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
7
  13.0%
1.Primary Outcome
Title Overall Survival (OS) for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab.
Hide Description Data will be analyzed using Kaplan-Meier curves. OS is defined as the time from first re-irradiation treatment until death from any cause.
Time Frame From treatment initiation and every 8 weeks for up to 53.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were eligible for this outcome measure with 2 patients not experiencing the event at time of analysis.
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: Months
8.5
(6.4 to 9.5)
2.Secondary Outcome
Title Patient Reported Quality of Life (QOL)
Hide Description

Questionnaires were completed before treatment (baseline) at the end of treatment (EOT) and after Cycle 1 and Cycle 2 of treatment (Initial phase of treatment =5 weeks + approximately 2 weeks recovery then adjuvant therapy where 1 cycle = 8 weeks). The following questionnaires were completed by patients to evaluate quality of life (QOL) at these timepoints:

FACT-Fatigue - scores from 1 to 4 with 1=not at all and 4=very much, the higher the score the more fatigue reported by the patient.

FACT-Brain (FACT Br) which included - Physcial Well-being (PWB), Social/Family Well-being (SWB), Emotional Well-being (EWB), and Functional Well-being (FWB).

Patients gave scores from 0 to 4 with 0=not at all and 4=very much, the higher the score the better the QOL reported by the patient.

Time Frame Completed before treatment (baseline) after Cycle 1 (approximately week 15) and Cycle 2 (approximately week 23)of adjuvant treatment and at the end of treatment (up to 7 cycles of adjuvant treatment, where 1 cycle =8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients where sufficient data was collected for analysis were considered evaluable for this endpoint and included.
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: score on a scale
FACT-BR Total : Baseline 130.4  (29.6)
FACT-BR Total : EOT 106.9  (61.4)
FACT-BR Total : Post Cycle 1 133.0  (18.8)
FACT-BR Total : Post Cycle 2 131.4  (10.2)
FACT-BR PWB : Baseline 22.0  (5.0)
FACT-BR PWB : EOT 21.6  (5.0)
FACT-BR PWB : Post Cycle 1 21.7  (4.4)
FACT-BR PWB : Post Cycle 2 21.1  (3.9)
FACT-BR SWB : Baseline 22.2  (5.4)
FACT-BR SWB : EOT 22.9  (4.3)
FACT-BR SWB : Post Cycle 1 23.0  (3.2)
FACT-BR SWB : Post Cycle 2 23.7  (3.0)
FACT-BR EWB : Baseline 15.9  (5.7)
FACT-BR EWB : EOT 16.5  (4.9)
FACT-BR EWB : Post Cycle 1 17.2  (3.3)
FACT-BR EWB : Post Cycle 2 17.7  (3.0)
FACT-FWB : Baseline 15.9  (6.9)
FACT-FWB : EOT 17.8  (4.8)
FACT-FWB : Post Cycle 1 17.0  (4.8)
FACT-FWB: Post Cycle 2 18.3  (3.3)
FACIT-Fatigue: Baseline 35.6  (10.3)
FACIT-Fatigue: EOT 30.3  (12.5)
FACIT-Fatigue: Post Cycle 1 34.4  (7.7)
FACIT-Fatigue: Post Cycle 2 36.2  (7.9)
3.Secondary Outcome
Title Safety Profile for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab
Hide Description

Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria on Day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 1 - 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected and graded as:

Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Time Frame Completed weekly during initial phase of 5 weeks and 2 weeks recovery, then every cycle during adjuvant therapy where 1 cycle =8 weeks (for up to 7 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received at least one dose of treatment on study were eligible for this outcome measure
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
Lymphopenia : Grade 1 4
Lymphopenia : Grade 2 12
Lymphopenia : Grade 3 4
Lymphopenia : Grade 4 1
Fatigue : Grade 1 9
Fatigue : Grade 2 5
Fatigue : Grade 3 1
Fatigue : Grade 4 0
Thrombocytopenia : Grade 1 8
Thrombocytopenia : Grade 2 1
Thrombocytopenia : Grade 3 2
Thrombocytopenia : Grade 4 1
Anemia : Grade 1 7
Anemia : Grade 2 1
Anemia : Grade 3 1
Anemia : Grade 4 0
Constipation : Grade 1 8
Constipation : Grade 2 1
Constipation : Grade 3 0
Constipation : Grade 4 0
Hypertension : Grade 1 0
Hypertension : Grade 2 6
Hypertension : Grade 3 1
Hypertension : Grade 4 0
Neutropenia : Grade 1 2
Neutropenia : Grade 2 3
Neutropenia : Grade 3 0
Neutropenia : Grade 4 0
Epistaxis : Grade 1 3
Epistaxis : Grade 2 0
Epistaxis : Grade 3 0
Epistaxis : Grade 4 0
Thromboembolism : Grade 1 0
Thromboembolism : Grade 2 1
Thromboembolism : Grade 3 1
Thromboembolism : Grade 4 0
Proteinuria : Grade 1 0
Proteinuria : Grade 2 0
Proteinuria : Grade 3 2
Proteinuria : Grade 4 0
Wound Complication : Grade 1 0
Wound Complication : Grade 2 0
Wound Complication : Grade 3 2
Wound Complication : Grade 4 0
4.Secondary Outcome
Title Percentage of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months
Hide Description Progression Free Survival is defined as the time from the first study treatment to the first occurrence of disease progression or death. Data will be analyzed using Kaplan-Meier curves. Tumor measurements and assessments will be based on Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (RANO criteria). Tumor assessments may include either a CT or MRI scan of the brain, however the same method should be used throughout the treatment period for each patient. In general, progressive disease is defined as any of the following: ≥ 25% increase in T1 gadolinium enhancing disease, increase in T2/Flair, new lesions present or decrease in clinical status
Time Frame At 6 and 12 months after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only evaluable patients that completed RT treatment, with follow up imaging and data for progression were included in this endpoint.
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: percentage of patients with PFS
6 Months 48
12 Months 12
5.Post-Hoc Outcome
Title Response of Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab
Hide Description

Best response is measured by CT/MRI and assessed by Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (RANO criteria).

In general best response will be defined as one of the following:

Complete Response: No T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions, no corticosteroid use and stable or increasing clinical status Partial Response: ≥ 50% decrease in T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions,stable or decreasing use of corticosteroids, and stable or increasing clinical status Stable Disease: < 50% decrease but < 25% increase T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions,stable or decreasing use of corticosteroids, and stable or increasing clinical status Progressive Disease is any of the following: ≥ 25% increase in T1 gadolinium enhancing disease, increase in T2/Flair, new lesions present or decrease in clinical status

Time Frame Every 8 weeks from the start of study treatment. Median time from beginning of initial radiation treatment was 25.3 months (range 8.1-82.4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
3
   5.6%
Partial Response
10
  18.5%
Stable Disease
28
  51.9%
Progressive Disease
9
  16.7%
Not Evaluable
4
   7.4%
6.Post-Hoc Outcome
Title Median Progression Free Survival (PFS) for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab
Hide Description Progression Free Survival (PFS) is defined as the time from the first study treatment to the first occurrence of disease progression or death. Data will be analyzed using Kaplan-Meier curves. Tumor measurements and assessments will be based on Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (RANO criteria). Tumor assessments may include either a CT or MRI scan of the brain, however the same method should be used throughout the treatment period for each patient. In general, progressive disease is defined as any of the following: ≥ 25% increase in T1 gadolinium enhancing disease, increase in T2/Flair, new lesions present or decrease in clinical status.
Time Frame Range from treatment initiation 0.4-26.9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only evaluable patients that completed RT treatment, with follow up imaging and data for progression were included in this endpoint.
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 42
Median (Full Range)
Unit of Measure: Months
5.5
(0.4 to 26.9)
7.Post-Hoc Outcome
Title Overall Survival (OS) at 6 Months and 12 Months for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab.
Hide Description Data will be analyzed using Kaplan-Meier curves. OS is defined as the time from first re-irradiation treatment until death from any cause. Percentages of patients alive at that 6 months and 12 months will be calculated from the Kaplan-Meier curve.
Time Frame At 6 and 12 months from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description:

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of patients alive
6 Months 67
12 Months 28
Time Frame Adverse events were collected from the first day of treatment until 30 days after the last treatment on study for up to approximately 67 weeks for any patient. Concurrent therapy was 5 weeks in length followed by 2 weeks recovery and then adjuvant therapy where 1 cycle = 8 weeks and range of cycles completed 0-7.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Hide Arm/Group Description

CONCURRENT THERAPY: Patients undergo hypofractionated radiation therapy 5 days a week beginning on Day 0. Patients also receive temozolomide PO QD and bevacizumab IV over 30-90 minutes once every 2 weeks beginning on Days -3 to 0. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.

ADJUVANT THERAPY: Beginning 2 weeks after completion of radiation therapy, patients receive temozolomide PO QD for 6 weeks and bevacizumab IV over 30-90 minutes once every 2 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Temozolomide: Given PO

Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy

Bevacizumab: Given IV

Questionnaire administration: Ancillary studies

All-Cause Mortality
Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Affected / at Risk (%)
Total   52/54 (96.30%) 
Hide Serious Adverse Events
Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Affected / at Risk (%)
Total   20/54 (37.04%) 
Gastrointestinal disorders   
Hemorrhoidal hemorrhage  1  1/54 (1.85%) 
General disorders   
Death NOS  1  5/54 (9.26%) 
Infections and infestations   
Wound Infection  1 [1]  1/54 (1.85%) 
Upper Respiratory Infection  1  1/54 (1.85%) 
Hepatic Infection  1  1/54 (1.85%) 
Injury, poisoning and procedural complications   
Fall  1  1/54 (1.85%) 
Wound Complication  1  1/54 (1.85%) 
Investigations   
Platelet Count Decreased  1  1/54 (1.85%) 
Metabolism and nutrition disorders   
Anorexia  1 [2]  1/54 (1.85%) 
Dehydration  1  1/54 (1.85%) 
Hyponatremia  1 [3]  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders   
Generalized Muscle Weakness  1  1/54 (1.85%) 
Muscle Weakness Right-sided  1 [4]  1/54 (1.85%) 
Nervous system disorders   
Seizure  1  4/54 (7.41%) 
Depressed Level of Consciousness  1 [5]  1/54 (1.85%) 
Headache  1  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders   
Hiccups  1 [6]  1/54 (1.85%) 
Vascular disorders   
Thromboembolic Event  1  2/54 (3.70%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Patient also with meningitis and wound dehiscence during this event
[2]
Patient also with constipation, decreased urine output, impaired hearing, diploplia, dysphagia, headache, hyperglycemia, and anemia. This SAE resulted in sudden death NOS
[3]
Patient had a seizure at the time of the event that was thought to be due to low sodium
[4]
Patient also with localized edema during this event
[5]
Patient with sinus bradycardia at time of the event
[6]
Patient also with shortness of breath due to the event
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Radiation, Chemotherapy, Monoclonal Antibody)
Affected / at Risk (%)
Total   54/54 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  12/54 (22.22%) 
Blood and lymphatic system disorders - Other, specify  1  1/54 (1.85%) 
Cardiac disorders   
Sinus bradycardia  1  1/54 (1.85%) 
Sinus tachycardia  1  2/54 (3.70%) 
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify  1  1/54 (1.85%) 
Ear pain  1  1/54 (1.85%) 
Hearing impaired  1  1/54 (1.85%) 
Vertigo  1  1/54 (1.85%) 
Endocrine disorders   
Hypothyroidism  1  2/54 (3.70%) 
Eye disorders   
Blurred vision  1  9/54 (16.67%) 
Dry eye  1  1/54 (1.85%) 
Extraocular muscle paresis  1  1/54 (1.85%) 
Eye disorders - Other, specify  1  2/54 (3.70%) 
Watering eyes  1  1/54 (1.85%) 
Gastrointestinal disorders   
Abdominal distension  1  1/54 (1.85%) 
Abdominal pain  1  1/54 (1.85%) 
Anal hemorrhage  1  1/54 (1.85%) 
Constipation  1  21/54 (38.89%) 
Diarrhea  1  3/54 (5.56%) 
Dry mouth  1  1/54 (1.85%) 
Dyspepsia  1  3/54 (5.56%) 
Dysphagia  1  2/54 (3.70%) 
Esophagitis  1  1/54 (1.85%) 
Fecal incontinence  1  3/54 (5.56%) 
Gastroesophageal reflux disease  1  4/54 (7.41%) 
Gastrointestinal disorders - Other, specify  1  1/54 (1.85%) 
Mucositis oral  1  3/54 (5.56%) 
Nausea  1  14/54 (25.93%) 
Oral pain  1  1/54 (1.85%) 
Vomiting  1  6/54 (11.11%) 
General disorders   
Chills  1  1/54 (1.85%) 
Edema limbs  1  2/54 (3.70%) 
Fatigue  1  31/54 (57.41%) 
Fever  1  1/54 (1.85%) 
Gait disturbance  1  15/54 (27.78%) 
Infusion site extravasation  1  1/54 (1.85%) 
Irritability  1  2/54 (3.70%) 
Localized edema  1  2/54 (3.70%) 
Malaise  1  1/54 (1.85%) 
Pain  1  6/54 (11.11%) 
Sudden death NOS  1  1/54 (1.85%) 
Immune system disorders   
Immune system disorders - Other, specify  1  1/54 (1.85%) 
Infections and infestations   
Infections and infestations - Other, specify  1  2/54 (3.70%) 
Meningitis  1  1/54 (1.85%) 
Peripheral nerve infection  1  1/54 (1.85%) 
Sinusitis  1  1/54 (1.85%) 
Tooth infection  1  1/54 (1.85%) 
Upper respiratory infection  1  1/54 (1.85%) 
Urinary tract infection  1  2/54 (3.70%) 
Injury, poisoning and procedural complications   
Bruising  1  1/54 (1.85%) 
Dermatitis radiation  1  7/54 (12.96%) 
Fall  1  3/54 (5.56%) 
Fracture  1  1/54 (1.85%) 
Wound dehiscence  1  1/54 (1.85%) 
Investigations   
Alanine aminotransferase increased  1  4/54 (7.41%) 
Alkaline phosphatase increased  1  2/54 (3.70%) 
Aspartate aminotransferase increased  1  6/54 (11.11%) 
Blood bilirubin increased  1  3/54 (5.56%) 
Cholesterol high  1  2/54 (3.70%) 
Creatinine increased  1  3/54 (5.56%) 
INR increased  1  1/54 (1.85%) 
Investigations - Other, specify  1  1/54 (1.85%) 
Lymphocyte count decreased  1  27/54 (50.00%) 
Lymphocyte count increased  1  1/54 (1.85%) 
Neutrophil count decreased  1  2/54 (3.70%) 
Platelet count decreased  1  20/54 (37.04%) 
Urine output decreased  1  1/54 (1.85%) 
Weight gain  1  3/54 (5.56%) 
Weight loss  1  10/54 (18.52%) 
White blood cell decreased  1  10/54 (18.52%) 
Metabolism and nutrition disorders   
Anorexia  1  11/54 (20.37%) 
Dehydration  1  5/54 (9.26%) 
Hyperglycemia  1  14/54 (25.93%) 
Hyperkalemia  1  1/54 (1.85%) 
Hypertriglyceridemia  1  2/54 (3.70%) 
Hypoalbuminemia  1  8/54 (14.81%) 
Hypocalcemia  1  8/54 (14.81%) 
Hypoglycemia  1  3/54 (5.56%) 
Hypokalemia  1  5/54 (9.26%) 
Hypomagnesemia  1  1/54 (1.85%) 
Hyponatremia  1  4/54 (7.41%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/54 (5.56%) 
Back pain  1  1/54 (1.85%) 
Joint range of motion decreased  1  1/54 (1.85%) 
Joint range of motion decreased cervical spine  1  1/54 (1.85%) 
Muscle weakness left-sided  1  7/54 (12.96%) 
Muscle weakness lower limb  1  3/54 (5.56%) 
Muscle weakness right-sided  1  7/54 (12.96%) 
Muscle weakness upper limb  1  1/54 (1.85%) 
Musculoskeletal and connective tissue disorder - Other, specify  1  2/54 (3.70%) 
Myalgia  1  1/54 (1.85%) 
Pain in extremity  1  1/54 (1.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  4/54 (7.41%) 
Nervous system disorders   
Akathisia  1  1/54 (1.85%) 
Amnesia  1  2/54 (3.70%) 
Ataxia  1  8/54 (14.81%) 
Cognitive disturbance  1  1/54 (1.85%) 
Dizziness  1  5/54 (9.26%) 
Dysarthria  1  3/54 (5.56%) 
Dysgeusia  1  2/54 (3.70%) 
Dysphasia  1  13/54 (24.07%) 
Edema cerebral  1  7/54 (12.96%) 
Encephalopathy  1  1/54 (1.85%) 
Facial nerve disorder  1  6/54 (11.11%) 
Headache  1  20/54 (37.04%) 
Hypersomnia  1  1/54 (1.85%) 
Lethargy  1  2/54 (3.70%) 
Memory impairment  1  11/54 (20.37%) 
Movements involuntary  1  1/54 (1.85%) 
Nervous system disorders - Other, specify  1  9/54 (16.67%) 
Paresthesia  1  5/54 (9.26%) 
Peripheral sensory neuropathy  1  4/54 (7.41%) 
Presyncope  1  1/54 (1.85%) 
Pyramidal tract syndrome  1  7/54 (12.96%) 
Seizure  1  20/54 (37.04%) 
Somnolence  1  2/54 (3.70%) 
Stroke  1  1/54 (1.85%) 
Tremor  1  5/54 (9.26%) 
Psychiatric disorders   
Anxiety  1  13/54 (24.07%) 
Confusion  1  9/54 (16.67%) 
Depression  1  13/54 (24.07%) 
Hallucinations  1  2/54 (3.70%) 
Insomnia  1  10/54 (18.52%) 
Personality change  1  2/54 (3.70%) 
Psychiatric disorders - Other, specify  1  1/54 (1.85%) 
Psychosis  1  1/54 (1.85%) 
Renal and urinary disorders   
Chronic kidney disease  1  1/54 (1.85%) 
Hematuria  1  1/54 (1.85%) 
Proteinuria  1  6/54 (11.11%) 
Renal and urinary disorders - Other, specify  1  2/54 (3.70%) 
Urinary frequency  1  1/54 (1.85%) 
Urinary incontinence  1  7/54 (12.96%) 
Urinary retention  1  2/54 (3.70%) 
Urinary tract pain  1  1/54 (1.85%) 
Urinary urgency  1  3/54 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  4/54 (7.41%) 
Aspiration  1  1/54 (1.85%) 
Cough  1  4/54 (7.41%) 
Dyspnea  1  1/54 (1.85%) 
Epistaxis  1  3/54 (5.56%) 
Nasal congestion  1  1/54 (1.85%) 
Postnasal drip  1  1/54 (1.85%) 
Pulmonary hypertension  1  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/54 (1.85%) 
Sneezing  1  1/54 (1.85%) 
Sore throat  1  3/54 (5.56%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  16/54 (29.63%) 
Nail loss  1  1/54 (1.85%) 
Pruritus  1  2/54 (3.70%) 
Purpura  1  1/54 (1.85%) 
Rash acneiform  1  2/54 (3.70%) 
Rash maculo-papular  1  3/54 (5.56%) 
Skin and subcutaneous tissue disorders - Other, specify  1  1/54 (1.85%) 
Urticaria  1  1/54 (1.85%) 
Vascular disorders   
Hypertension  1  20/54 (37.04%) 
Thromboembolic event  1  4/54 (7.41%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
The study was closed to accrual before the accrual goal was met due to slow accrual
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karan Dixit, MD
Organization: Northwestern University
Phone: 312-695-1301
EMail: karan.dixit@northwestern.edu
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01478321    
Other Study ID Numbers: NU 11C02
STU00053636 ( Other Identifier: Northwestern University IRB )
NCI CTRP# ( Other Identifier: NCI-2011-02904 )
First Submitted: November 17, 2011
First Posted: November 23, 2011
Results First Submitted: January 30, 2020
Results First Posted: March 12, 2020
Last Update Posted: March 12, 2020