Glioblastoma MultiformePhase 1NCT02049489
A Study of ICT-121 Dendritic Cell Vaccine in Recurrent Glioblastoma
A Phase 1 study testing ICT-121 DC vaccine in people with Glioblastoma Multiforme, run by Precision Life Sciences Group at 6 sites in United States.
Trial summary
This study will evaluate a type of immunotherapy in which the patient's immune system will be stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's white blood cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ICT-121 DC vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2013to Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any recurrence of a glioblastoma multiforme
- ≥ 18 years of age
- Human leukocyte antigen HLA A2 positive
- Karnofsky Performance Score (KPS) of ≥ 70%
- Baseline hematologic studies and chemistry profiles must meet the following criteria:
- hemoglobin (Hgb) > 9.9 g/dL
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- absolute neutrophil count (ANC) > 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) ≤ 1.6 x control unless therapeutically warranted
- 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)
- Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
- Ability to understand and the willingness to sign a written informed consent document.
- Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks prior to first treatment
Who cannot join
- 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, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
- New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
- Uncontrolled or significant cardiovascular disease, including:
- Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
- Uncontrolled angina within 6 months
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- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
- Clinically significant abnormality on electrocardiogram (ECG)
- Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
- Severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following:
- Immunosuppressive disease
- Chronic renal disease / failure
- Concurrent neurodegenerative disease,
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
- Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
- Known history of an autoimmune disorder
- Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
- Breastfeeding
- Received any other therapeutic investigational agent within 30 days of screening, except for immunotherapy. Patients with previous immunotherapy are not eligible regardless of timing.
- Contraindication to MRI
- Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Baylor Research Institute - Charles A. Sammons Cancer Center
Dallas, Texas, 75246
JFK New Jersey Neuroscience Institute
Edison, New Jersey, 08820
Penn State Hershey Neuroscience Institute
Hershey, Pennsylvania, 17033
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Immunological Targeting of CD-133 in Recurrent Glioblastoma: A Multi-center Phase I Translational and Clinical Study of an Autologous CD-133 DC Vaccine
This study will evaluate a type of immunotherapy in which the patient's immune system will be stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be collected from blood and cultured to yield autologous DC. The DC will be mixed with purified peptides from the CD133 antigen. The DC vaccine will be given back to the patient over several months. The goal is to stimulate the patient's immune system to CD133 to kill the patient's glioblastoma tumor cells.
Read the detailed description
Immunotherapy holds promise in oncology for the potential to provide targeted anti-tumor therapy with minimal adverse events. The goal of this study is to assess immunotherapy directed to CD133 in an autologous dendritic cell product called ICT-121. CD133 antigen is overexpressed on many types of cancer cells and is associated with shortened survival. CD133 positive cancer stem cells are resistant to chemotherapy. Patients with recurrent glioblastoma who have the HLA A2 phenotype will receive autologous vaccine of DC pulsed with purified peptides from CD133.
Approximately 20 patients with any recurrence of glioblastoma multiforme (GBM) will be treated. After informed consent and screening, patients will undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). Monocytes will be purified and cultured into dendritic cells (DC) that are pulsed with purified peptides from CD133 antigen. The pulsed dendritic cells will then be aliquoted and frozen. Patients will have the autologous DCs reinfused intradermally. Patients will receive at least four intradermal injections of the autologous DC vaccine and additional vaccines during a maintenance phase. The goal is to induce a cytotoxic T cell response to CD133 positive cells. The primary objective of the study is to assess safety and tolerability. Clinical response rates will be monitored as well as the immune responses to CD133.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ICT-121 DC vaccine
- Keywords
- ICT-121, glioblastoma, immunotherapy, dendritic cell vaccine, CD133
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICT-121 DC vaccineBiological
autologous dendritic cells pulsed with peptide antigens
| Study group | Role | What they receive |
|---|---|---|
| ICT-121 DC vaccine | Experimental | Autologous dendritic cells pulsed with peptide antigens Receives: Biological: ICT-121 DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of an autologous ICT-121 DC vaccine
To assess safety of the autologous ICT-121 DC vaccine the following will be monitored: Serious Adverse events, treatment emergent adverse events, treatment related toxicities
Measured: 2-3 years
Secondary outcomes (1)
Response rate and immune response to autologous ICT-121 DC vaccine
The following parameters for response rate and immune response will be measured:
The rates of OS and PFS assessed every 2 months until the end of the study; Health-related quality of life parameters in patients treated as above; Post vaccination biopsy/resection (optional) - Assess antigen expression; Overall response rate, defined as the percentage of patients showing either partial response or complete response, will be assessed in patients with measurable disease on MRI; Predictors of response; Immune Response (cytotoxic T-Cell response) to the ICT-121 DC vaccine epitopes.
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02049489
- Sponsor's protocol ID
- ICT-121 DC-01
- Status last verified
- Aug 2018
- First submitted
- 28 Jan 2014
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Targeting of CD-133 in Recurrent Glioblastoma: A Multi-center Phase I Translational and Clinical Study of an Autologous CD-133 DC Vaccine
- ClinicalTrials.gov ID
- NCT02049489
- Acronym / sponsor ID
- ICT-121 DC-01
- Conditions
- Glioblastoma Multiforme
- Keywords
- ICT-121, glioblastoma, immunotherapy, dendritic cell vaccine, CD133
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Precision Life Sciences GroupIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a type of immunotherapy in which the patient's immune system will be stimulated to kill tumor cells. ICT-121 dendritic cell (DC)vaccine is made from patient's white blood cells. This vaccine will be tested in patients with recurrent glioblastoma to assess safety, tolerability and clinical response. Patient's white blood cells (WBC) will be collected from blood and cultured to yield autologous DC. The DC will be mixed with purified peptides from the CD133 antigen. The DC vaccine will be given back to the patient over several months. The goal is to stimulate the patient's immune system to CD133 to kill the patient's glioblastoma tumor cells.
Detailed description
Immunotherapy holds promise in oncology for the potential to provide targeted anti-tumor therapy with minimal adverse events. The goal of this study is to assess immunotherapy directed to CD133 in an autologous dendritic cell product called ICT-121. CD133 antigen is overexpressed on many types of cancer cells and is associated with shortened survival. CD133 positive cancer stem cells are resistant to chemotherapy. Patients with recurrent glioblastoma who have the HLA A2 phenotype will receive autologous vaccine of DC pulsed with purified peptides from CD133.
Approximately 20 patients with any recurrence of glioblastoma multiforme (GBM) will be treated. After informed consent and screening, patients will undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). Monocytes will be purified and cultured into dendritic cells (DC) that are pulsed with purified peptides from CD133 antigen. The pulsed dendritic cells will then be aliquoted and frozen. Patients will have the autologous DCs reinfused intradermally. Patients will receive at least four intradermal injections of the autologous DC vaccine and additional vaccines during a maintenance phase. The goal is to induce a cytotoxic T cell response to CD133 positive cells. The primary objective of the study is to assess safety and tolerability. Clinical response rates will be monitored as well as the immune responses to CD133.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICT-121 DC vaccine | Experimental | Biological: ICT-121 DC vaccineAutologous dendritic cells pulsed with peptide antigens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Any recurrence of a glioblastoma multiforme
- ≥ 18 years of age
- Human leukocyte antigen HLA A2 positive
- Karnofsky Performance Score (KPS) of ≥ 70%
- Baseline hematologic studies and chemistry profiles must meet the following criteria:
Key exclusion criteria (22 listed)
- 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, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
- New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
- Uncontrolled or significant cardiovascular disease, including:
- Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03
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-121 DC vaccineautologous dendritic cells pulsed with peptide antigens | Biological | ICT-121 DC vaccine |
Primary outcome
Safety and tolerability of an autologous ICT-121 DC vaccine
Time frame: 2-3 years
To assess safety of the autologous ICT-121 DC vaccine the following will be monitored: Serious Adverse events, treatment emergent adverse events, treatment related toxicities
1 secondary outcome
Response rate and immune response to autologous ICT-121 DC vaccine
Time frame: 2-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICT-121 DC vaccine in people with Glioblastoma Multiforme, run by Precision Life Sciences Group at 6 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 17 inclusion and 22 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of an autologous ICT-121 DC vaccine (time frame: 2-3 years). 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 13 Aug 2018.