A Phase II Study of Ofranergene Obadenovec in People with Advanced Glioblastoma to Be Treated with Surgery

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Full Title

A Randomized, Controlled Phase II Surgical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters for the Viral Cancer Therapy Ofranergene Obadenovec (VB-111) in Patients with Surgically Accessible Recurrent/Progressive Glioblastoma

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational treatment ofranergene obadenovec (VB-111) in people with advanced glioblastoma whose tumors have come back or continued to grow despite treatment and will be surgically removed. VB-111 cuts off the blood supply to some kinds of tumors, which may prevent tumors from growing. It is given intravenously (by vein).

Participants in this study will be randomly assigned to receive one of these treatments:

  • VB-111 before and after surgery
  • A placebo (inactive medication) before surgery and VB-111 after surgery
  • A placebo before surgery and standard treatment after surgery

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have grade IV malignant glioblastoma or gliosarcoma that has come back or continued to grow despite one or two prior regimens of treatment.
  • Patients must be planning to have glioma surgery.
  • The serious side effects of prior treatments must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to inquire about eligibility for this study, please contact Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 866-886-9807.

Protocol

21-264

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Ingo Mellinghoff