Brain cancer vaccine trial combines custom peptides with electric fields
NCT ID NCT03223103
First seen Jun 26, 2026 · Last updated Sep 21, 2026 · Updated 2 times
Summary
This early-phase trial tests whether a personalized vaccine made from each patient's tumor mutations, combined with Tumor Treating Fields (a device that sends electric fields to the brain), is safe and feasible for people with newly diagnosed glioblastoma. The 13 participants receive the vaccine alongside standard care. The main goals are to check for side effects and see if the vaccine can be successfully made and given.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized mutation-derived tumor vaccine (peptides) plus Poly-ICLC (Hiltonol) and Tumor Treating Fields (Optune device)
- What this could lead to
- If successful, this could point toward a new way to treat glioblastoma by combining a personalized vaccine with standard care to help the immune system target the tumor.
- What could go wrong
- This is a very early (Phase 1) and small (13 people) trial focused on safety, not effectiveness. The vaccine is custom-made for each patient, which is complex and may not work for everyone. There is also a risk of side effects from the vaccine or device.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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13 people
The number who actually took part.
- Started
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Mar 2018
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 * Histological confirmation of GBM (WHO grade IV). * Stable disease after treatment of radiation with concurrent chemotherapy. If the disease is not stable or progresses while in the study the patient is allowed to continue the study receiving the vaccine if the tumor gets controlled by other modality treatment(s) * Must have received maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide (45-70Gy) * Life expectancy \> 16 weeks * Performance status of 0-2 as determined by Eastern Cooperative Oncology Group (ECOG) and/or Karnofsky Performance Status (KPS) 70-100 * First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant Temozolomide or radiotherapy * Must have archival tumor tissue that is sufficient quantity and quality for sequencing * Have adequate bone marrow function * Requires Dexamethasone ≤ 4mg daily on a stable dose * Acceptable hematologic, hepatic, and renal function and these tests must be performed within 14 days prior to study * Must be deemed competent to give informed consent * Must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry, and continuing to do so for the duration of participation in the study Exclusion Criteria: * Progression of disease at time of screening * Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias * Infra-tentorial tumor or multifocal disease * History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to Decarbazine (DTIC) * Receiving any other investigational agents. Patient is allowed to get another investigational agent and to continue receiving the vaccine only if the disease progresses while in the study and the other investigational agent is a reasonable choice to treat the patient * Active cancer at the time of screening * Prior history of unrelated neoplastic disease, and having received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation. * History of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), chronic hepatitis B or hepatitis C or is otherwise reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression * History of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression; or the subject is currently receiving any drug or supplement which is known to be associated with systemic immune suppression including those drugs which are prescribed for solid organ or stem cell transplant, autoimmune/inflammatory disorders, or other related medical conditions * History of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: Vitiligo, diabetes, or thyroid dysfunction * Less than 18 years of age, or otherwise unable to give informed consent due to minor status * Prisoner, as defined by \[45 CFR 46.303(c)\] * Cognitively impaired, and unable to give informed consent * Pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test \[45 CFR 46.203(b)\] * Requires or is likely to require more than a 2-week course of corticosteroids of \>4mg
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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