Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT03223103
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03223103
Study Brief:
Protocol Section:
NCT03223103