Glioblastoma Clinical Trials

TRIAL 1 Study Description:

This study will evaluate two different therapies used in combination with an immune enhancer (checkpoint inhibitor) to treat dogs with high grade glioma (HGG) or glioblastoma (GBM). Dogs with a single brain mass that is amenable to surgical resection will be eligible for the study. All dogs will have a surgical resection of their tumor.

In the first study, dogs will be treated with a series of vaccinations using the patient’s own tumor lysate, an immune response modifier and a checkpoint inhibitor starting 10 days after surgery. Vaccines are given once a week for 3 weeks, once every 4 weeks for 3 months, then once every 8 weeks until the end of the one-year study period.

In the second study, dogs will be treated with an immune-based gene therapy locally around the tumor resection site. Dogs will be treated with angancyclovir for 10 days post surgery to induce death of genetically modified tumor cells. In both cases, dogs will have follow up physical and neurological exams and MRIs at 4, 8 and 12 months after surgery.

If MRI suggests changes have occurring at the tumor site then patients will undergo a stereotactic guided biopsy of the area to distinguish between tumor progression or immune response. If clinical signs such as worsening of neurological signs or cluster seizures occur, then dogs will receive alternative medical management or undergo euthanasia based on the wishes of the owner.

Location/Study Sites:

University of Minnesota

Study Type:

Interventional (therapeutic)

Primary Study Contact:

Dr. Elizabeth Pluhar
pluha006@umn.edu

Inclusion Criteria:

• Any dog with a solitary intracranial mass diagnosed with magnetic resonance imaging (MRI) consistent with a glioma and suitable for surgical resection
• Normal mentation status at the time of surgery
• Histologic confirmation of a high-grade (III-IV) glioma
• Informed consent provided by owner

Exclusion Criteria:

• Severe neurologic dysfunction, especially changes in level of consciousness
• Tumor not amenable to surgical resection
• Existence of concomitant disease that would affect the dog’s long-term prognosis and preclude completion of chemotherapy or vaccine therapy
• Dogs with a histological diagnosis other than high grade glioma or glioblastoma
• Unwillingness to complete the treatments and follow-up proscribed in the protocol without a compelling reason.