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Molecular Combinatorial Therapy for Canine Malignant Gliomas

Purpose

To determine the safety and effectiveness of a new chemotherapy drug and drug delivery method in the treatment of brain tumors (gliomas) in dogs.

Background

Dogs and humans are the only species in which primary brain tumors are common. In dogs, a type of malignant tumor called a glioma accounts for approximately 35% of all spontaneous primary brain tumors. Even with treatment, the prognosis for both dogs and humans with gliomas is poor, and there is no cure. Current therapies such as radiation aim at extending quantity and improving quality of life.

In this clinical trial, we are testing the safety and effectiveness of molecularly targeted cytotoxins, which are chemotherapeutic drugs, delivered directly to the patient's brain tumor. Developed by researchers at the Thomas K. Hearn Brain Tumor Research Center at the Wake Forest School of Medicine, the unique chemotherapeutic drugs used in this trial are designed to affect only cancerous cells, and not normal brain tissue. Earlier generations of these molecularly targeted cyotoxins have been used safely and effectively in dogs with gliomas. Using specialized catheters the cytotoxins are infused directly into the tumor over a several hour period. The drug treatment is monitored continuously with MRI to allow the neurosurgeon to precisely track the drug delivery.

Eligibility

  • Dogs of any age, breed, or sex > 3 and < 45 kg body weight
  • Clinical signs of mild to moderate neurologic dysfunction referable to the brain
  • MRI evidence of a single telencephalic intra-axial mass lesion consistent with a glioma
  • Dogs must have gross, measurable disease (> 1cm in diameter) on a current MRI
  • No clinical or other diagnostic evidence of other significant systemic disease

Exclusion Criteria

  • Dogs that are not expected to survive for the length of the study period based on clinical progression of tumor
  • Dogs that have received immunotherapy in the previous 6 months
  • Dogs that have received cytotoxic (standard) chemotherapy in the previous 6 weeks
  • Dogs that have had surgery in the previous 6 weeks
  • Dogs that have received radiation therapy
  • Dogs with uncontrolled seizures

Study Design

The treatment administered in the trial involves a procedure termed Convection Enhanced Delivery (CED) of molecularly targeted cytotoxins, which are types of chemotherapeutic drugs, to the patient’s brain tumor. CED is performed by inserting specialized catheters directly into the tumor, and slowly infusing the drugs over a several hour period. Enrolled dogs typically remain in the hospital for 5-7 days for a biopsy procedure, the CED procedure, and post-treatment recovery. Dogs will return for outpatient recheck MRI examinations every 2-3 months for up to one year.

Compensation

Owner is responsible for the cost of obtaining an MRI to confirm diagnosis. Once the diagnosis is confirmed and the dog is enrolled, all treatment and follow-up examinations related to this study will be provided at no cost during the study period. Owners are responsible for travel-related expenses and medication costs associated with ongoing seizure control, if required.

Contact

Mindy Quigley, Clinical Trials Coordinator
Office Phone: 540-231-1363 | Email: mindyq@vt.edu

Dr. John Rossmeisl, Principal Investigator
Email: jrossmei@vt.edu

If your query is urgent, please call the Small Animal Hospital on 540-231-4621 and ask for the neurologist on duty.

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