SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Glioblastoma
- Gliosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate 6-month progression-free survival (PFS6) in patients with survivin positive newly diagnosed glioblastoma multiforme (GBM) treated with at least 4 doses of SVN53-67/M57-keyhole limpet hemocyanin (KLH) peptide vaccine (SurVaxM) and standard of care temozolomide. SECO...
PRIMARY OBJECTIVES: I. To evaluate 6-month progression-free survival (PFS6) in patients with survivin positive newly diagnosed glioblastoma multiforme (GBM) treated with at least 4 doses of SVN53-67/M57-keyhole limpet hemocyanin (KLH) peptide vaccine (SurVaxM) and standard of care temozolomide. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of SurVaxM in patients receiving standard care adjuvant temozolomide. II. To evaluate overall survival (OS) in patients with survivin positive newly diagnosed GBM treated with SurVaxM and adjuvant temozolomide. III. To describe the immune response in patients treated with SurVaxM and predictors of response. IV. To evaluate objective tumor response rate (applicable only for patients with evaluable disease at study entry, as defined per Response Assessment in Neuro-Oncology [RANO] criteria) and predictors of response. OUTLINE: Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 subcutaneously (SC) and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide orally (PO) or intravenously (IV) on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks.
Tracking Information
- NCT #
- NCT02455557
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Robert Fenstermaker Roswell Park Cancer Institute