NCT01250470

Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma

Phase I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Survivin-Positive Malignant Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anaplastic Astrocytoma
• Anaplastic Oligoastrocytoma
• Anaplastic Oligodendroglioma
• Giant Cell Glioblastoma
• Glioblastoma
• Gliosarcoma
• Mixed Glioma
• Recurrent Brain Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Montanide ISA-51/Survivin Peptide Vaccine	Given SC
BIOLOGICAL	Sargramostim	Given SC

Timeline

• Start date: 2012-09-05
• Primary completion: 2014-05-29
• Completion: 2014-05-29
• First posted: 2010-11-30
• Last updated: 2017-02-27

Locations

1 site across 1 country: United States