Glioblastoma Clinical Trial
Official title:
Phase I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Survivin-Positive Malignant Gliomas
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.
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