This is a bi-institutional pilot study between the University of Pittsburgh Cancer Institute and the Comprehensive Cancer Center of Wake Forest University of a vaccination regime (subcutaneous injections of glioma-associated antigen [GAA]-derived cytotoxic T-lymphocyte [CTL] epitope-peptides with simultaneous intramuscular [i.m.] administration of poly-ICLC) that is designed to efficiently induce anti-tumor T-cell responses in adults with either World Health Organization (WHO) grade II astrocytoma or oligoastrocytoma with poor prognostic factors. The overall objective of this pilot study is to collect immunological and safety data to decide whether a larger study of clinical efficacy is warranted. Unfavorable subsets of adult patients with supratentorial low grade glioma (LGG) are defined as ones with astrocytoma or oligoastrocytoma histology and either one of the following conditions: 1) age e 40 with any extent resection;2) age 18-39 with incomplete resection, or 3) age 18-39 with neurosurgeon- defined gross total resection but the tumor size is e 4 cm in diameter. These patients have as high as an 89% risk of suffering disease recurrence at 5 years following surgery. However, the slower growth rate of LGG (in contrast to malignant gliomas) should allow sufficient time to administer multiple immunizations, which may lead to the induction of high levels of GAA-specific immunity. Because patients with LGG are likely not to be as immune-compromised as patients with higher-grade gliomas, they may exhibit greater immunological responses. In addition, poly-ICLC has been demonstrated to enhance the vaccine effects in preclinical brain tumor models, and to be safe in malignant glioma patients. Therefore, we hypothesize that this form of vaccine in combination with poly-ICLC treatment will safely induce potent anti-glioma immune response. Participants will be treated with s.c. injections of GAA-vaccines every 3 weeks for 8 times and poly-ICLC will be administered (20 This is a bi-institutional pilot study between the University of Pittsburgh Cancer Institute and the Comprehensive Cancer Center of Wake Forest University of a vaccination regime (subcutaneous injections of glioma-associated antigen-derived cytotoxic T-lymphocyte epitope-peptides with simultaneous intramuscular administration of poly-ICLC) that is designed to efficiently induce anti-tumor T-cell responses in adults with World Health Organization grade II astrocytoma or oligoastrocytoma with poor prognostic factors. The overall objective of this pilot study is to collect immunological and safety data that will be used to decide whether a larger study of clinical efficacy is warranted.Public Health Relevance
| Okada, Hideho; Butterfield, Lisa H; Hamilton, Ronald L et al. (2015) Induction of robust type-I CD8+ T-cell responses in WHO grade 2 low-grade glioma patients receiving peptide-based vaccines in combination with poly-ICLC. Clin Cancer Res 21:286-94 |
| Pollack, Ian F; Jakacki, Regina I; Butterfield, Lisa H et al. (2013) Ependymomas: development of immunotherapeutic strategies. Expert Rev Neurother 13:1089-98 |
| Okada, Hideho; Pollack, Ian F (2011) Do we need novel radiologic response criteria for brain tumor immunotherapy? Expert Rev Neurother 11:619-22 |
