CTIM-21. PEPTIDE VACCINE DIRECTED TO CMV pp65 FOR TREATMENT OF RECURRENT MALIGNANT GLIOMA AND MEDULLOBLASTOMA IN CHILDREN AND YOUNG ADULTS: PRELIMINARY RESULTS OF A PHASE I TRIAL
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2020-11-09
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<jats:title>Abstract</jats:title> <jats:sec> <jats:title>INTRODUCTION</jats:title> <jats:p>The cytomegalovirus (CMV) antigen, pp65, is ubiquitously expressed in malignant glioma and medulloblastoma but not in healthy brain. The objective of this Phase I trial (NCT03299309) was to assess the safety and feasibility of a novel pp65 peptide vaccine (PEP-CMV) in children and young adults with recurrent medulloblastoma and malignant glioma.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>Vaccines contain a synthetic long peptide (SLP) of 26 amino acids encoding multiple potential class I, class II, and antibody epitopes of CMV pp65 across several haplotypes. This SLP is administered as an emulsion in Montanide ISA 51. Patients receive a single course of temozolomide to induce lymphopenia, tetanus/diphtheria toxoid site preconditioning, then vaccines administered intradermally every two weeks for 3 doses, then monthly.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>To date, 17 patients have been enrolled. Diagnoses include medulloblastoma (n=1), glioblastoma (n=9), anaplastic oligodendroglioma (n=2), anaplastic astrocytoma (n=2), and malignant glioma NOS (n=3). Mean number of prior treatment regimens is 4.9 (range 1–12). Mean age is 22yo (range 6–35) and 41% of patients are male. The median KPS is 80. The median number of vaccines given at time of analysis is 3.3 (range 1–12). There have been no ≥ 3 Grade toxicities related to the vaccine. One patient developed nausea, vomiting, palpitations, and tachycardia after vaccination and had elevated inflammatory cytokines consistent with cytokine release syndrome. Median PFS is 2.5 months (95% CI: 0.8, not estimable) and median OS is 6.5 months (95% CI 1.8, not estimable). Interim analysis of immune monitoring bloodwork and perfusion MRI to quantify responses to PEP-CMV has been delayed due to COVID-19. However, adults with GBM who received PEP-CMV (NCT02864368) had significant (p≤0.05) increases in GCSF, GM-CSF, IFN-γ, IL-10, IL-2, IL-8, MIP1-α, and TNF-α levels.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>Preliminary results demonstrate that PEP-CMV is feasible and well-tolerated in heavily pretreated, multiply recurrent patients.</jats:p> </jats:sec>
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Thompson, Eric, Daniel Landi, Eric Lipp, Bea Balajonda, James Herndon, Evan Buckley, Charlene Flahiff, Denise Jaggers, et al. (2020). CTIM-21. PEPTIDE VACCINE DIRECTED TO CMV pp65 FOR TREATMENT OF RECURRENT MALIGNANT GLIOMA AND MEDULLOBLASTOMA IN CHILDREN AND YOUNG ADULTS: PRELIMINARY RESULTS OF A PHASE I TRIAL. Neuro-Oncology, 22(Supplement_2). pp. ii37–ii37. 10.1093/neuonc/noaa215.155 Retrieved from https://hdl.handle.net/10161/24048.
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Scholars@Duke
Daniel Bryce Landi
Kristin M. Schroeder
I have a strong belief that all children diagnosed with cancer should have the same chance of cure regardless of where they live. Since 2014, i have spent six or more months per year in Mwanza, Tanzania, at the Bugando Medical Centre as part of the Duke Global Cancer Program. In addition to developing capacity for pediatric cancer care, my research focuses on creating interventions to improve outcomes and reducing treatment abandonment in low resource settings.
As a trained pediatric neuro-oncologist, I am also involved in neuro-oncology capacity development in Sub-Saharan Africa, and am collaborating with a multidisciplinary team in Tanzania to establish diagnostic and treatment opportunities for patients.
Margaret Johnson
I am a neuro-oncologist, neurologist, and palliative care physician at the Preston Robert Tisch Brain Tumor Center. I also provide neuro-oncology expertise for the National Tele-Oncology Program and National Precision Oncology Program at the Veteran's Health Administration. My clinical and research interests encompass supportive care and palliative care with a special interest in older adults with brain tumors. The incidence of malignant brain tumors like glioblastoma and non-malignant tumors like meningioma affect aging populations and it is crucial to be able to provide better care for these patients.
Mustafa Khasraw
I am a physician-scientist with a background in medical oncology and neuro-oncology, with affiliations to multiple departments, research, and training programs at Duke.
I lead a Tumor Immunobiology Laboratory where we use various wet and dry lab techniques to understand the interactions between tumors and the immune system. Our goal is to identify vulnerabilities that can be targeted for novel therapies.
I serve as the Deputy Director of the Center for Cancer Immunotherapy at the Duke Cancer Institute where we are tasked to facilitate clinical research and translate promising discoveries made by scientists across various departments and cancer types at Duke, particularly in the field of immune and T cell-based therapies.
My team and our laboratory operate in an environment that enables the transition from bench-side basic scientific discoveries to clinical trials, and back to the bench ensuring the evaluation of new treatments for cancer patients.
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