This phase I trial studies the side effects of vaccine therapy when given together with sargramostim in treating patients with malignant glioma. Vaccines made from survivin peptide may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy and sargramostim may be a better treatment for malignant glioma.
PRIMARY OBJECTIVES: I. To determine the toxicity profile of the SVN53-67/M57-KLH peptide in Montanide ISA 51 (Montanide ISA-51/survivin peptide vaccine) plus with GM-CSF (sargramostim). SECONDARY OBJECTIVES: I. To measure the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 with GM-CSF. TERTIARY OBJECTIVES: I. To collect preliminary data on therapeutic efficacy of this combination against malignant glioma. OUTLINE: Patients receive Montanide ISA-51/survivin peptide vaccine subcutaneously (SC) followed by sargramostim SC on day 0. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at weeks 12, 16, 20, and 24. TREATMENT EXTENSION: After completion of study treatment, select patients may receive additional doses of Montanide ISA-51/survivin peptide vaccine SC and sargramostim SC. Treatment repeats every 3 months in the absence of disease progression or unacceptable toxicity. After completion of treatment extension, patients are followed up at 1 month.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Roswell Park Cancer Institute
Buffalo, New York, United States
Incidence of toxicity, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4
The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. In addition, descriptive statistics will be utilized to present the toxicity findings in the treatment extension group.
Time frame: Up to 30 days post-treatment
Immune response, defined as a patient who has responded in either interferon gamma enzyme-linked immunosorbent spot (ELISPOT) or multimer assays
For both assays, time course and magnitude of responses will be plotted and data will be treated using mixed-effect modeling. In addition, Fisher's exact test will be used to determine whether ELISPOT and multimer responses are associated. Additional exploratory analyses will be done as appropriate, and will be data-driven; hypothesis testing is not anticipated. Results will be displayed in plots and tables. In addition, descriptive statistics will be utilized to present the immunological findings in the treatment extension group.
Time frame: Up to 6 months post-treatment
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