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Radiation Therapy and Temozolomide Followed by Temozolomide and Poly ICLC in Treating Patients With Newly Diagnosed GBM

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ClinicalTrials.gov Identifier: NCT00262730
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : July 16, 2014
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Interventions Drug: poly ICLC
Drug: temozolomide
Radiation: radiation therapy
Enrollment 97
Recruitment Details outpatient clinic
Pre-assignment Details  
Arm/Group Title Treatment Arm - All Subjects
Hide Arm/Group Description

poly ICLC, temozolomide, radiation: radiation therapy

poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)

temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)

radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy

Period Title: Overall Study
Started 97
Completed 97
Not Completed 0
Arm/Group Title Treatment Arm - All Subjects
Hide Arm/Group Description

poly ICLC, temozolomide, radiation: radiation therapy

poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)

temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)

radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy

Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 97 participants
56.6
(21 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
37
  38.1%
Male
60
  61.9%
Karnofsky Performance Status   [1] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 97 participants
100 34
90 45
80 12
70 3
60 3
[1]
Measure Description: 100 normal no complaints no disease 90 capable of normal activity few symptoms/disease 80 normal activity with some difficulty some symptoms or signs 70 caring for self not capable of normal activity or work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care and help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures or treatment 10 moribund rapidly progressive fatal disease processes 0 death
Extent of surgery  
Measure Type: Number
Unit of measure:  Patient
Number Analyzed 97 participants
Biopsy 18
Craniotomy 79
time from diagnosis to radiotherapy  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 97 participants
4.4
(2 to 12.6)
Baseline Mini-Mental State Examiniation (MMSE) Score   [1] 
Measure Type: Number
Unit of measure:  Scores on a Scale
Number Analyzed 97 participants
30 56
27-29 30
Less than or equal 26 11
[1]
Measure Description: The mini–mental state examination (MMSE) is a 30-point questionnaire test used to screen for cognitive impairment. Commonly used to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. The Higher your score, the higher your function.
Corticosteroid Therapy  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 97 participants
Yes 70
No 26
Missing Data 1
Histologic Diagnosis  
Measure Type: Number
Unit of measure:  Patient
Number Analyzed 97 participants
Glioblastoma 94
Anaplastic Astrocytoma 1
Other 2
1.Primary Outcome
Title Survival
Hide Description survival time is defined from time of histological diagnosis to death occurrence.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
all patients who were treated were analyzed (intent to treat)
Arm/Group Title Treatment Arm - All Subjects
Hide Arm/Group Description:

poly ICLC, temozolomide, radiation: radiation therapy

poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)

temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)

radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy

Overall Number of Participants Analyzed 97
Mean (95% Confidence Interval)
Unit of Measure: months
17.2
(15.4 to 19.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Arm - All Subjects
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.
Statistical Test of Hypothesis P-Value >.1
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.8 to 0.85
Parameter Dispersion
Type: Standard Deviation
Value: .025
Estimation Comments [Not Specified]
Time Frame While on Treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm All Subjects
Hide Arm/Group Description

poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy

AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI

All-Cause Mortality
Treatment Arm All Subjects
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment Arm All Subjects
Affected / at Risk (%) # Events
Total   20/97 (20.62%)    
Blood and lymphatic system disorders   
febrile neutropenia  1  2/97 (2.06%)  2
hemoglobin increased * 1  2/97 (2.06%)  2
leukopenia * 1  16/97 (16.49%)  16
Gastrointestinal disorders   
Diarrhea * 1  1/97 (1.03%)  1
vomiting * 1  1/97 (1.03%)  1
General disorders   
fatigue * 1  3/97 (3.09%)  3
Infections and infestations   
Lung infection * 1 [1]  1/97 (1.03%)  1
Investigations   
aspartate aminotransferase increased * 1  1/97 (1.03%)  1
Neutrophils/granulocytes (ANC/AGC) * 1  20/97 (20.62%)  20
platelet count decreased * 1  9/97 (9.28%)  9
Musculoskeletal and connective tissue disorders   
muscle weakness, generalized * 1  1/97 (1.03%)  1
Nervous system disorders   
nausea * 1  1/97 (1.03%)  1
Skin and subcutaneous tissue disorders   
rash * 1 [2]  2/97 (2.06%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
pneumonia
[2]
desquamation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Arm All Subjects
Affected / at Risk (%) # Events
Total   97/97 (100.00%)    
Blood and lymphatic system disorders   
febrile neutropenia * 1  3/97 (3.09%)  3
anemia * 1  71/97 (73.20%)  760
hemoglobin increase * 1  2/97 (2.06%)  2
leukocytes * 1 [1]  2/97 (2.06%)  2
lymphopenia * 1  1/97 (1.03%)  1
PLTS * 1  59/97 (60.82%)  468
PO4 * 1  19/97 (19.59%)  31
platelets * 1  2/97 (2.06%)  3
Cardiac disorders   
pain - cardiac/heart/chest * 1  3/97 (3.09%)  3
palpitations * 1  4/97 (4.12%)  4
supraventricular and nodal arrhythmia * 1 [2]  1/97 (1.03%)  1
supraventricular and nodal arrhythmia * 1 [3]  1/97 (1.03%)  1
supraventricular and nodal arrhythmia * 1 [4]  1/97 (1.03%)  1
Ear and labyrinth disorders   
ear and labyrinth disorder * 1 [5]  4/97 (4.12%)  4
hearing * 1 [6]  4/97 (4.12%)  4
otitis * 1 [7]  2/97 (2.06%)  2
pain - external ear * 1  1/97 (1.03%)  1
pain - middle ear * 1  3/97 (3.09%)  3
tinnitus * 1  7/97 (7.22%)  9
Endocrine disorders   
cushingoid * 1  8/97 (8.25%)  8
endocrine * 1  1/97 (1.03%)  1
Eye disorders   
cataract * 1  1/97 (1.03%)  1
dry eye * 1  3/97 (3.09%)  3
ocular/vision disorder * 1  2/97 (2.06%)  2
diplopia (double vision) * 1  3/97 (3.09%)  4
pain - eye * 1  2/97 (2.06%)  2
photosensitivity * 1  1/97 (1.03%)  1
vision - blurred * 1  16/97 (16.49%)  20
vision - flashing lights/floaters * 1  4/97 (4.12%)  4
watery eye * 1 [8]  1/97 (1.03%)  1
Gastrointestinal disorders   
ascites * 1  1/97 (1.03%)  1
colitis * 1  3/97 (3.09%)  3
constipation * 1  38/97 (39.18%)  52
periodontal disease * 1  1/97 (1.03%)  1
diarrhea * 1  13/97 (13.40%)  19
distension/bloating * 1  1/97 (1.03%)  1
dry mouth * 1  2/97 (2.06%)  2
dysphagia * 1  3/97 (3.09%)  3
gastritis * 1  3/97 (3.09%)  3
gastrointestinal * 1  4/97 (4.12%)  8
dyspepsia * 1  12/97 (12.37%)  12
rectal hemorrhage * 1  1/97 (1.03%)  1
mucositis oral * 1  11/97 (11.34%)  12
nausea * 1  41/97 (42.27%)  64
pain - abdomen * 1  2/97 (2.06%)  2
pain - dental/teeth/peridontal * 1  1/97 (1.03%)  1
pain - oral * 1  1/97 (1.03%)  1
pain - stomach * 1  2/97 (2.06%)  2
taste alteration * 1 [9]  11/97 (11.34%)  12
ulceration * 1  1/97 (1.03%)  2
General disorders   
cough * 1  18/97 (18.56%)  22
edema * 1 [10]  5/97 (5.15%)  5
edema * 1 [11]  19/97 (19.59%)  28
fatigue * 1  70/97 (72.16%)  112
fever * 1 [12]  9/97 (9.28%)  13
flu like symptoms * 1  3/97 (3.09%)  4
pain - chest/thorax * 1  4/97 (4.12%)  6
pain - other * 1  4/97 (4.12%)  4
rigors/chills * 1  5/97 (5.15%)  7
syndromes - other * 1  1/97 (1.03%)  1
Hepatobiliary disorders   
International Normalized Ratio of prothrombin time * 1  2/97 (2.06%)  2
Immune system disorders   
allergic reaction * 1  2/97 (2.06%)  2
Infections and infestations   
esophageal hemorrhage * 1  1/97 (1.03%)  1
infection * 1 [13]  42/97 (43.30%)  45
Injury, poisoning and procedural complications   
bruising * 1  12/97 (12.37%)  17
fracture * 1  1/97 (1.03%)  1
injury * 1 [14]  1/97 (1.03%)  1
rash * 1 [15]  20/97 (20.62%)  20
Investigations   
Alkaline phosphatase increased * 1  19/97 (19.59%)  66
blood bicarbonate decreased * 1  10/97 (10.31%)  13
creatinine increased * 1  3/97 (3.09%)  3
Neutrophils/granulocytes (ANC/AGC) * 1  3/97 (3.09%)  3
PTT * 1  4/97 (4.12%)  10
SGOT/AST * 1  18/97 (18.56%)  37
SGPT/ALT * 1  34/97 (35.05%)  131
total bilirubin * 1  3/97 (3.09%)  5
white blood cells * 1  64/97 (65.98%)  793
Metabolism and nutrition disorders   
anorexia * 1  28/97 (28.87%)  35
dehydration * 1  3/97 (3.09%)  3
hyperglycemia * 1  1/97 (1.03%)  3
hypercalcemia * 1  6/97 (6.19%)  9
hyperglycemia * 1  65/97 (67.01%)  246
hyperkalemia * 1  15/97 (15.46%)  32
hypermagnesemia * 1  18/97 (18.56%)  27
hypernatremia * 1  12/97 (12.37%)  20
hypocalcemia * 1  18/97 (18.56%)  33
hypoglycemia * 1  20/97 (20.62%)  41
hypokalemia * 1  18/97 (18.56%)  32
hypomagnesemia * 1  6/97 (6.19%)  9
hyponatremia * 1  20/97 (20.62%)  53
hyperkalemia * 1  1/97 (1.03%)  1
hypokalemia * 1  3/97 (3.09%)  4
hyponatremia * 1  2/97 (2.06%)  2
uric acid * 1  6/97 (6.19%)  13
weight gain * 1  2/97 (2.06%)  2
weight loss * 1  10/97 (10.31%)  10
Musculoskeletal and connective tissue disorders   
arthritis * 1  1/97 (1.03%)  1
extremity - lower (gait/walking) * 1 [16]  1/97 (1.03%)  1
joint function * 1  2/97 (2.06%)  2
lumbar spine range of motion decreased * 1  1/97 (1.03%)  1
muscle weakness, generalized or specific area * 1  33/97 (34.02%)  43
soft tissue * 1  5/97 (5.15%)  7
pain - back * 1  8/97 (8.25%)  10
pain - bone * 1  1/97 (1.03%)  1
pain - extremity * 1  14/97 (14.43%)  16
pain - joint * 1  16/97 (16.49%)  21
pain - muscle * 1  17/97 (17.53%)  23
pain - neck * 1  6/97 (6.19%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
hyperpigmentation * 1  1/97 (1.03%)  1
Nervous system disorders   
ataxia * 1  10/97 (10.31%)  12
ischemia cerebrovascular * 1  3/97 (3.09%)  3
cognitive disturbance * 1  2/97 (2.06%)  2
confusion * 1  18/97 (18.56%)  26
dizziness * 1  24/97 (24.74%)  28
encephalopathy * 1  1/97 (1.03%)  1
hemorrhage * 1 [17]  1/97 (1.03%)  1
hydrocephalus * 1  4/97 (4.12%)  4
memory impairment * 1  27/97 (27.84%)  32
neurological disorder * 1  8/97 (8.25%)  8
neuropathy * 1  58/97 (59.79%)  80
headache * 1  51/97 (52.58%)  80
pyramidal tract dysfunction * 1  1/97 (1.03%)  1
seizure * 1  34/97 (35.05%)  68
somnolence * 1  4/97 (4.12%)  4
speech impairment * 1 [18]  22/97 (22.68%)  34
syncope * 1  3/97 (3.09%)  3
thrombosis/thrombus/embolism * 1  12/97 (12.37%)  14
tremor * 1  6/97 (6.19%)  6
Psychiatric disorders   
insomnia * 1  20/97 (20.62%)  26
libido decreased * 1  2/97 (2.06%)  2
mood alteration * 1  36/97 (37.11%)  39
personality/behavioral disorder * 1  1/97 (1.03%)  1
psychosis * 1  3/97 (3.09%)  3
Renal and urinary disorders   
cystitis * 1  1/97 (1.03%)  1
hemorrhage * 1 [19]  1/97 (1.03%)  1
urinary incontinence * 1  4/97 (4.12%)  5
obstruction * 1 [20]  2/97 (2.06%)  2
urinary frequency * 1  3/97 (3.09%)  3
urinary retention * 1  3/97 (3.09%)  3
Reproductive system and breast disorders   
pain - breast * 1  1/97 (1.03%)  1
vaginal discharge * 1  1/97 (1.03%)  1
Respiratory, thoracic and mediastinal disorders   
allergic rhinitis * 1  4/97 (4.12%)  4
dyspnea * 1  15/97 (15.46%)  18
hemorrhage * 1 [21]  2/97 (2.06%)  2
hiccups * 1  1/97 (1.03%)  1
hypoxia * 1  1/97 (1.03%)  1
paranasal sinus reaction * 1  2/97 (2.06%)  2
pneumothorax * 1  1/97 (1.03%)  1
pulmonary/upper respiratory * 1  2/97 (2.06%)  2
voice changes * 1 [22]  2/97 (2.06%)  2
Skin and subcutaneous tissue disorders   
dermatology/skin * 1  5/97 (5.15%)  5
dry skin * 1  4/97 (4.12%)  5
alopecia * 1  39/97 (40.21%)  39
nail changes * 1  1/97 (1.03%)  1
pain - scalp * 1  3/97 (3.09%)  3
pain - skin * 1  3/97 (3.09%)  3
pruritus/itching * 1  9/97 (9.28%)  11
purpura * 1  2/97 (2.06%)  3
rash - acneiform * 1  4/97 (4.12%)  4
rash - desquamation * 1  20/97 (20.62%)  27
skin breakdown/decubitus ulcer * 1  1/97 (1.03%)  1
sweating (diaphoresis) * 1  3/97 (3.09%)  3
urticaria * 1  1/97 (1.03%)  1
Vascular disorders   
flushing * 1  1/97 (1.03%)  1
hot flashes * 1  2/97 (2.06%)  2
hypertension * 1  2/97 (2.06%)  2
hypotension * 1  7/97 (7.22%)  9
vascular - other * 1  2/97 (2.06%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
total white blood cell count
[2]
atrial fibrillation
[3]
atrial tachycardia/paroxysmal atrial tachycardia
[4]
sinus tachycardia
[5]
other
[6]
w/o baseline audiogram & no monitoring program
[7]
external ear, middle ear
[8]
epiphora, tearing
[9]
dysgeusia
[10]
head and neck
[11]
limbs
[12]
in absence of neutropenia
[13]
bladder (urinary)
[14]
intra-operative brain injury
[15]
associated with radiation (chemoradiation & radiation)
[16]
gait disturbance
[17]
CNS
[18]
dysphasia or aphasia
[19]
urinary
[20]
ureter, bladder
[21]
nose
[22]
hoarseness, loss or alteration in voice, laryngitis
"Other Adverse Events" not reported for this study. Only serious(grade 3/4)related to either TMZ and/or Poly were reported. Subjects may have experienced grade 1 and grade 2 other adverse event but they have no bearing on clinical outcome of agent
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Director of Adult Brain Tumor Consortium
Organization: Adult Brain Tumor Consortium Central Office- Johns Hopkins
Phone: 410-955-3657
EMail: jfisher@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00262730    
Other Study ID Numbers: NABTT-0501
U01CA062475 ( U.S. NIH Grant/Contract )
NABTT-0501 CDR0000454915
NA_00001963 ( Other Identifier: JHM IRB )
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: March 22, 2013
Results First Posted: July 16, 2014
Last Update Posted: June 12, 2019