ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM
United States24 participantsStarted 2023-08-30
Plain-language summary
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A\*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years of age
✓. Newly diagnosed Isocitrate dehydrogenase (IDH) wild type (CARIS result), MGMT promoter unmethylated (CARIS result) WHO grade IV glioma (e.g., glioblastoma (GBM) or high grade glioma with molecular features of GBM) with definitive resection prior to enrollment, and residual radiographic contrast enhancement on immediate post-surgical computed tomography (CT), or magnetic resonance imaging (MRI).
✓. CMV positive or negative by IgG testing.
✓. Karnofsky Performance Status (KPS) of \> 70%.
✓. Serum creatinine ≤ 3 x the upper limit of normal (ULN), serum glutamic oxaloacetic transaminase (SGOT)≤ 3 times ULN
✓. Bilirubin ≤ 1.5 times ULN (Exception: Patient has known Gilbert's Syndrome or patient has suspected Gilbert's Syndrome, for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)
✓. Signed informed consent approved by the Institutional Review Board.
Exclusion criteria
✕. Patients with known potentially anaphylactic allergic reactions to gadolinium-diethylenetriaminepentaacetic acid (DTPA), or any component of the tetanus-diphtheria vaccine.
✕. Patients with evidence of tumor in the brainstem, cerebellum, or spinal cord, radiological evidence of multifocal disease, or leptomeningeal disease.
What they're measuring
1
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
Timeframe: Approximately 2 months after initiation of P30-EPS study vaccine
✕. Areas of high-grade glioma outside the original radiation field on the post XRT/TMZ MRI.
✕. Patients who cannot undergo MRI.
✕. Severe, active comorbidity, including any of the following:
✕. Co-medication that may interfere with study results (e.g., immuno-suppressive agents other than corticosteroids).
✕. Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin. (Treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment.)
✕. Patients are not permitted to have had any other conventional therapeutic intervention other than surgery, steroids, and standard of care chemoradiation prior to enrollment.