Glioblastoma MultiformePhase 2NCT01280552
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
A Phase 2 study testing ICT-107 in people with Glioblastoma Multiforme, run by Precision Life Sciences Group at 25 sites in United States.
Trial summary
This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ICT-107
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2011to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation.
- ≥ 18 years of age
- HLA-A1 or HLA-A2 positive
- KPS score of ≥ 70%
- Baseline hematologic studies and chemistry profiles must meet the following criteria:
- Hemoglobin (Hgb) > 9.9 g/dL total granulocyte count > than 1000/mm3 platelet count > 100,000/mm3 blood urea nitrogen (BUN) < 30 mg/dL creatinine < 2 mg/dL alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 4x upper limit of normal (ULN) prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x control unless therapeutically warranted
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- Female patients of child-bearing potential must have negative serum pregnancy test
- If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
- Sufficient paraffin embedded tumor sample for analysis MGMT methylation status
- Written informed consent, Release of Medical Records Form and Health Insurance Portability and Accountability Act (HIPAA) reviewed and signed by patient or legally authorized representatives
Who cannot join
- Recurrent disease
- Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer
- Presence of any other active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin)
- Severe pulmonary, cardiac or other systemic disease
- Congestive heart failure Class III or IV according to New York Heart Association (NYHA)
- Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
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- Known history of an autoimmune disorder
- Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness
- Breastfeeding
- Received any other therapeutic investigational agent within 30 days of enrollment
- Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to the first administration of study vaccine
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Massachusetss General Hospital
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
Cleveland, Ohio, 44195
Sammons Cancer Center (Baylor)
Dallas, Texas, 75246
New Jersey Neuroscience Institute
Edison, New Jersey, 08818
The Long Island Brain Tumor Center at Neurological Surgery, PC
Great Neck, New York, 11021
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas Health Science Center at Houston
Houston, Texas, 77030
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Jewish Hospital Medical Center
Louisville, Kentucky, 40245
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
NYU Clinical Cancer Center
New York, New York, 10016
Weil Cornell Medical College
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Alabama at Birbingham School of Medicine
South Birmingham, Alabama, 35294
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Arizona Cancer Center
Tucson, Arizona, 85724
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation
This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.
Read the detailed description
The proposed phase 2 study is a randomized, double blind, controlled study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemoradiation. The phase 1 clinical trial demonstrated safety and promising efficacy in a small, open-label study. The purpose of this study is to provide information from a larger, controlled clinical trial. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Patients will have had tumor resection, magnetic resonance imaging (MRI) and tumor assessment prior to enrollment into the study. Post surgical treatment consists of 6 weeks of chemotherapy (TMZ) and radiation followed by a washout period. After Screening and informed consent, patients will undergo apheresis at the study site for collection of peripheral blood mononuclear cells (PBMCs). Apheresis product will be sent to a central site where monocytes will be purified and cultured into dendritic cells (DC). DC will be pulsed with synthetic peptides that correspond to immunogenic epitopes of tumor antigens. The pulsed dendritic cells will then be aliquoted and frozen before shipping back to the site. Patients will have the autologous DCs reinfused intradermally. A control group will receive unpulsed autologous DC. Patients will be randomized by age in a 2:1 ratio to ICT-107 or control.Patients will receive at least four intradermal injections of the ICT-107 vaccine and additional vaccine during a maintenance phase. The primary objective is to compare overall survival (OS) and progression free survival (PFS) in patients when treated with ICT-107 versus Control.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ICT-107, Placebo DC
- Keywords
- Glioblastoma Multiforme
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICT-107Biological
Autologous dendritic cells pulsed with immunogenic antigens
Placebo DCBiological
Autologous dendritic cells (DC) that have not been pulsed with antigens
| Study group | Role | What they receive |
|---|---|---|
| ICT-107 | Experimental | Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens Receives: Biological: ICT-107 |
| Control | Placebo comparator | Autologous dendritic cells that have not been pulsed with antigens Receives: Biological: Placebo DC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
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
Measured: 2 -3 years
Overall Survival in HLA-A2 Patients
Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
Measured: 2-3 years
Secondary outcomes (2)
PFS
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.
Measured: 2-3 years
Progression Free Survival in HLA- A2 Patients
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
Measured: 2-3 yers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision Life Sciences Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Gringeri, Ph.D., Study director, Precision Life Sciences Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280552
- Sponsor's protocol ID
- ICT-107-201
- Status last verified
- Feb 2017
- First submitted
- 19 Jan 2011
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation
- ClinicalTrials.gov ID
- NCT01280552
- Acronym / sponsor ID
- ICT-107-201
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Precision Life Sciences GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.
Detailed description
The proposed phase 2 study is a randomized, double blind, controlled study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemoradiation. The phase 1 clinical trial demonstrated safety and promising efficacy in a small, open-label study. The purpose of this study is to provide information from a larger, controlled clinical trial. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Patients will have had tumor resection, magnetic resonance imaging (MRI) and tumor assessment prior to enrollment into the study. Post surgical treatment consists of 6 weeks of chemotherapy (TMZ) and radiation followed by a washout period. After Screening and informed consent, patients will undergo apheresis at the study site for collection of peripheral blood mononuclear cells (PBMCs). Apheresis product will be sent to a central site where monocytes will be purified and cultured into dendritic cells (DC). DC will be pulsed with synthetic peptides that correspond to immunogenic epitopes of tumor antigens. The pulsed dendritic cells will then be aliquoted and frozen before shipping back to the site. Patients will have the autologous DCs reinfused intradermally. A control group will receive unpulsed autologous DC. Patients will be randomized by age in a 2:1 ratio to ICT-107 or control.Patients will receive at least four intradermal injections of the ICT-107 vaccine and additional vaccine during a maintenance phase. The primary objective is to compare overall survival (OS) and progression free survival (PFS) in patients when treated with ICT-107 versus Control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICT-107 | Experimental | Biological: ICT-107Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens |
| Control | Placebo comparator | Biological: Placebo DCAutologous dendritic cells that have not been pulsed with antigens |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation.
- ≥ 18 years of age
- HLA-A1 or HLA-A2 positive
- KPS score of ≥ 70%
- Baseline hematologic studies and chemistry profiles must meet the following criteria:
Key exclusion criteria (11 listed)
- Recurrent disease
- Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer
- Presence of any other active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin)
- Severe pulmonary, cardiac or other systemic disease
- Congestive heart failure Class III or IV according to New York Heart Association (NYHA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICT-107Autologous dendritic cells pulsed with immunogenic antigens | Biological | ICT-107 |
| Placebo DCAutologous dendritic cells (DC) that have not been pulsed with antigens | Biological | Control |
Primary outcome
Overall Survival (OS)
Time frame: 2 -3 years
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
Overall Survival in HLA-A2 Patients
Time frame: 2-3 years
Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
2 secondary outcomes
PFS
Time frame: 2-3 years
Progression Free Survival in HLA- A2 Patients
Time frame: 2-3 yers
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Gringeri, Ph.D. study director
Precision Life Sciences Group
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICT-107 in people with Glioblastoma Multiforme, run by Precision Life Sciences Group at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 2 -3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.