Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas

Participants must have documented pathological diagnosis of a WHO grade II astrocytoma or oligoastrocytoma or oligodendroglioma (see also the 4th bullet for oligodendroglioma).

HLA-A2 positive based on flow cytometry.

There will be 2 cohorts of patients based on whether patients have received prior RT. Cohort 1: patients must have undergone surgery or biopsy alone ≤16 weeks prior to study entry (no postoperative radiation or chemotherapy). Cohort 2: Patients received surgery or biopsy and radiation therapy (RT) (including fractionated external beam radiation therapy and/or stereotactic radiosurgery), which was completed ≥6 months prior to enrollment, and have a baseline MRI scan (within 4 weeks of the first vaccine) that shows stable disease or regression.

For oligodendroglioma, at least one of the following three conditions has to be met: 1) age ≥ 40 with any extent resection; 2) age 18-39 with incomplete resection (post-op MRI showing \> 1cm residual disease, based on the maximum dimension of residual T2 or FLAIR abnormality from the edge of the surgical cavity either laterally, antero-posteriorly, or supero-inferiorly) or 3) age 18-39 with neurosurgeon-defined GTR but the tumor size is ≥ 4 cm (the maximum preoperative tumor diameter, based on the axial and/or coronal T2 or FLAIR MR images). Participants must be ≥ 18 years old because the safety of each therapeutic component has not been established in children.

All participants must sign an informed consent document indicating that they are aware of the investigational nature of this study.

Participants must have a Karnofsky performance status of \> 60 (Appendix I).

Documented negative serum beta HCG for female participants of child-bearing age. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the peptide based vaccine and poly-ICLC, breastfeeding should be discontinued if the mother is treated in this study.

Participants must be free of systemic infection

Participants with adequate organ function as measured by white blood count ≥ 2500/mm3; lymphocytes ≥ 800/mm3; platelets ≥ 100,000/mm3, hemoglobin ≥ 10.0 g/dL, AST, ALT, GGT, LDH, alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin greater than or equal to 2.0 mg/dL, and serum creatinine within 1.5 X upper limit of normal limit. Coagulation tests PT and PTT have to be within normal limits.

What this study is about