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A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)

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: NCT01280552
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : October 7, 2014
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Precision Life Sciences Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Glioblastoma Multiforme
Interventions Biological: ICT-107
Biological: Placebo DC
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ICT-107 Placebo
Hide Arm/Group Description

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

Period Title: Overall Study
Started 81 43
Completed 75 [1] 42
Not Completed 6 1
[1]
Survival is still being assessed
Arm/Group Title ICT-107 Placebo Total
Hide Arm/Group Description

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

Total of all reporting groups
Overall Number of Baseline Participants 81 43 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 43 participants 124 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
59
  72.8%
29
  67.4%
88
  71.0%
>=65 years
22
  27.2%
14
  32.6%
36
  29.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 43 participants 124 participants
Female
37
  45.7%
12
  27.9%
49
  39.5%
Male
44
  54.3%
31
  72.1%
75
  60.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 81 participants 43 participants 124 participants
81 43 124
1.Primary Outcome
Title Overall Survival (OS)
Hide Description The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control. OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis
Time Frame 2 -3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat include all randomized patients
Arm/Group Title ICT-107 Control Dendritic Cells
Hide Arm/Group Description:
Treatment with autologous dendritic cells pulsed with immunogenic peptides
Treatment with autologous dendritic cells not pulsed with immunogenic peptides
Overall Number of Participants Analyzed 81 43
Median (95% Confidence Interval)
Unit of Measure: months of survival
18.3
(14.9 to 21.2)
16.7
(12.3 to 23.0)
2.Primary Outcome
Title Overall Survival in HLA-A2 Patients
Hide Description Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
Time Frame 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with HLA-A2 haplotype
Arm/Group Title ICT-107 Control
Hide Arm/Group Description:

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

Overall Number of Participants Analyzed 48 29
Median (95% Confidence Interval)
Unit of Measure: months of survival
18.3
(13.2 to 21.1)
12.9
(10.2 to 19.1)
3.Secondary Outcome
Title PFS
Hide Description

Secondary Endpoints

  • PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed.
  • Population is all randomized patients ITT.
Time Frame 2-3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat includes all randomized patients
Arm/Group Title ICT-107 Placebo
Hide Arm/Group Description:

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

Overall Number of Participants Analyzed 81 43
Median (95% Confidence Interval)
Unit of Measure: months of progression free survival
11.2
(8.2 to 13.0)
9.0
(5.5 to 10.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ICT-107, Placebo
Comments Stratified log rank p value stratified for age and MGMT methylation status
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments Stratified for age and MGMT methylation status
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Progression Free Survival in HLA- A2 Patients
Hide Description

Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype.

Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed

Time Frame 2-3 yers
Hide Outcome Measure Data
Hide Analysis Population Description
HLA-A2 patients
Arm/Group Title ICT-107 Placebo
Hide Arm/Group Description:

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

Overall Number of Participants Analyzed 48 29
Median (95% Confidence Interval)
Unit of Measure: months of progression free survival
11.2
(6.5 to 14.0)
7.2
(4.6 to 10.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ICT-107, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments Analyses were stratified for age and MGMT methylation status.
Method Log Rank
Comments [Not Specified]
Time Frame 3 years
Adverse Event Reporting Description Safety population was defined as those receiving at least one dose. This included 80 patients for ICT-107 and 43 patients in the Control group.
 
Arm/Group Title ICT-107 Placebo
Hide Arm/Group Description

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

ICT-107: Autologous dendritic cells pulsed with immunogenic antigens

Autologous dendritic cells that have not been pulsed with antigens

Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens

All-Cause Mortality
ICT-107 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
ICT-107 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/80 (10.00%)   7/43 (16.28%) 
Infections and infestations     
infection  1  4/80 (5.00%)  4/43 (9.30%) 
Nervous system disorders     
seizure  1  8/80 (10.00%)  7/43 (16.28%) 
cerebral edema  1  2/80 (2.50%)  1/43 (2.33%) 
intracranial hemorrhage  1  4/80 (5.00%)  0/43 (0.00%) 
increased intracranial pressure  1  2/80 (2.50%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
pulmonary embolism  1  0/80 (0.00%)  3/43 (6.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
ICT-107 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   59/80 (73.75%)   40/43 (93.02%) 
Blood and lymphatic system disorders     
thrombocytopenia  1  3/80 (3.75%)  3/43 (6.98%) 
Gastrointestinal disorders     
nausea  1  6/80 (7.50%)  4/43 (9.30%) 
General disorders     
fatigue  1  12/80 (15.00%)  11/43 (25.58%) 
Infections and infestations     
urinary tract infection  1  5/80 (6.25%)  2/43 (4.65%) 
upper respiratory tract infection  1  0/80 (0.00%)  3/43 (6.98%) 
Investigations     
white blood cell count decreased  1  4/80 (5.00%)  0/43 (0.00%) 
Metabolism and nutrition disorders     
decreased appetite  1  2/80 (2.50%)  3/43 (6.98%) 
Musculoskeletal and connective tissue disorders     
musular weakness  1  2/80 (2.50%)  6/43 (13.95%) 
Nervous system disorders     
convulsion  1  11/80 (13.75%)  7/43 (16.28%) 
headache  1  2/80 (2.50%)  7/43 (16.28%) 
hemiparesis  1  4/80 (5.00%)  2/43 (4.65%) 
partial seizure  1  5/80 (6.25%)  1/43 (2.33%) 
Psychiatric disorders     
insomnia  1  3/80 (3.75%)  4/43 (9.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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: Anthony Gringeri, Ph.D. Senior Vice President Strategic Resources
Organization: ImmunoCellular Therapeutics Ltd.
Phone: 818 264 2300
EMail: anthony.gringeri@imuc.com
Layout table for additonal information
Responsible Party: Precision Life Sciences Group
ClinicalTrials.gov Identifier: NCT01280552    
Other Study ID Numbers: ICT-107-201
First Submitted: January 19, 2011
First Posted: January 20, 2011
Results First Submitted: October 2, 2014
Results First Posted: October 7, 2014
Last Update Posted: March 20, 2017