COLORADO
Study: Canine Brain Tumor Vaccine Clinical Trial
Location:  Colorado State University--Fort Collins, Colorado
Contact: Kara Hall at csuoncologytrials@colostate.edu or 1-970-297-4001
www.csuanimalcancercenter.org/canine-brain-tumor-vaccine-clinical-trial

Eligibility:
Dogs with glioma type tumors based on MRI characteristics. Patients must still be in overall good health and stable
condition. Not dependent on prednisone to control clinical signs. Seizures (if occurring) must be controlled with anti-
convulsant medication. Measureable disease present and visible on MRI.

Needle biopsy and/or surgical debulking are permitted, but must have residual measurable disease.

Prior radiation therapy allowed if recurrence has been documented and confirmed prior to enrollment; signed owner
informed consent.

Purpose: Evaluation of preliminary tumor response to vaccine that targets cancer stem cells as well as vaccine tolerability.

Procedures: 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.

Benefits: Partially funded (owner cost expected <$500).

INDIANA
Study: Metronomic Chemotherapy for Brain Tumors in Dogs
Location:  Purdue University-West Lafayette, Indiana
Contact: Dr. Timothy Bentley at rbentley@purdue.edu or 1-765-496-9715
http://vet.purdue.edu/pcop/neurooncology.php

Eligibility:
Dogs that have been tentatively diagnosed with a glioma brain tumor by MRI. Dr. Bentley must confirm the suspicion of
glioma by reviewing the MRI before enrollment. Chest radiographs and bloodwork must also have been performed (within
the last month).

Summary: Combination surgery and chemotherapy for glioma brain tumors in dogs, including a repeat MRI at 3 months.
Samples to test the chemotherapy concentrations will be taken during the study.

Benefits: The brain tumor surgery, the chemotherapy, the bloodwork to monitor the chemotherapy and the repeat MRI will
all be provided at no charge.

VIRGINIA
Study: Evaluation of a novel gene therapy (GEN-1) for the treatment of canine glioblastoma
Location:  Veterinary Referral & Critical Care--Manakin-Sabot, 1596 Hockett Road, Manakin-Sabot, VA 23103
Contact:
Anna Aman at anna_aman@icloud.com or 1-804-784-8722 or frontdeskvrcc@gmail.com

Eligibility:
Any dog that is approximately 10 Kg in weight or greater with an intra-axial brain tumor and that is healthy enough to
undergo resection surgery can be included in this study. The specific tumor type will not be an eligibility requirement
although there will be requirements regarding the location of the tumor that will inform a final eligibility decision.

Summary: This project is a collaborative effort between Celsion Corporation and veterinarians at Veterinary Referral &
Critical Care (VRCC) of Manakin-Sabot, VA evaluating a novel gene therapy (GEN-1) for the treatment of brain tumors.
The goal of this project is to evaluate the safety and feasibility of intra-cranially administering GEN-1 following tumor
resection surgery. The results of this study will be used to support the initiation of clinical trials aimed at treating human
patients with glioblastoma multiforme.


The following treatment design will be used: ● Surgery to remove as much of the tumor as possible. ● Subcutaneous
implantation of a reservoir device with access to the resection cavity ● Repeated administration (3x) of the gene therapy
(GEN-1) through the device directly into the resection cavity. .

Procedures: In this study, GEN-1, a nanoparticle formulation that contains the IL-12 gene will be repeatedly delivered
intra-cranially into dogs following tumor resection surgery. IL-12 protein is known to have very potent anti-tumor
properties that work by stimulating the body’s own immune response to help kill tumor cells. In addition, IL-12 can also
help to prevent the formation of new blood vessels that are required for tumor growth. Use of GEN-1 is currently being
evaluated in human clinical trials for treating ovarian cancer and has shown in animal models that it can slow and/or
eliminate a wide variety of tumor types, including glioblastomas. Although this study is designed to evaluate the feasibility
and safety of repeatedly administering GEN-1 into the resection cavity in the brain that has resulted from surgically
removing a brain tumor, it has the potential to reduce or eradicate the remaining tumor in dogs suffering from brain
cancer.


Benefits: All project related treatments, analytical work and followup will be performed at no cost to the dog's owners.
Owners will be responsible for transportation to and from VRCC for treatments and follow-up visits. .

Study: Molecular Combinatorial Therapy for Canine Malignant Gliomas
Location:  Virginia-Maryland College of Veterinary Medicine
Contact: Mindy Quigley, Clinical Trials Coordinator; (540) 231-1363 | Email: vettrials@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.
www.vetmed.vt.edu/clinical-trials/current-studies/molecular-combinatorial-therapy.asp

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
No clinical or other diagnostic evidence of other significant systemic disease

Summary: This clinical trial is a collaboration between the Virginia-Maryland Regional College of Veterinary Medicine and
the Thomas K. Hearn Brain Tumor Research Center at the Wake Forest School of Medicine. 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. The chemotherapeutic drugs used in this trial are
unique in that they are designed to affect only cancerous cells, and not normal brain tissue. Previous generations of one
of the drugs (IL-13PE38QQR) used in this trial have been used safely in human brain tumor clinical trials.

Procedures: 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.

Benefits: 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.

WASHINGTON
Study: A study of the safety and effectiveness of Toca 511, a replication competent murine leukemia
virus with a cytosine deaminase gene, administered transcranially to companion dogs with
spontaneous brain tumors and followed by oral treatment with 5 fluorocytosin
Location:  Washington State University College of Veterinary Medicine
Contact: Valorie Wiss, Clinical Studies Coordinator; Office: 509-335-0798; Cell: 509-432-5345; vwiss@vetmed.wsu.edu
http://vcs.vetmed.wsu.edu/research/clinical-studies/brain-tumor-rx

Eligibility:
Dogs enrolled in this study must have a diagnosis of a brain tumor.  They need to be deemed healthy enough, by a
neurologist, to undergo anesthesia, a brain biopsy procedure, brain surgery to remove the tumor, viral infusions and MRI
scans.  Following the viral infusion, dogs will be required to remain at WSU-VTH for at least five days.  Two to six weeks
after viral infusion, each dog will either begin taking the oral drug 5-FC or will undergo surgery to remove the tumor and
then begin taking 5-FC.  Every four weeks, owners will need to give the oral drug to their dogs for five days.  For six
months following the start of 5-FC, dogs will need to return to WSU-VTH every eight weeks for a neurologic exam, blood
work and an MRI.  If in the unfortunate event that the dog dies during the study period, an autopsy is required to confirm
the cause of death.

Summary: The purpose of this study is to evaluate the safety and effectiveness of combining gene therapy with 5-FC (an
anti-fungal drug) to treat primary brain tumors in dogs.  This treatment has shown promise in mouse brain tumors and is
currently in clinical trials in humans with brain tumors.  An effective standard treatment for canine brain tumors has not
been established in veterinary medicine.  Current possible therapies include surgical removal, radiation therapy and
chemotherapy, but canine responses to these therapies have been poorly documented and survival times have been
unclear.  Using gene therapy to treat brain tumors can be beneficial because only the tumor, and not the entire body,
would receive the cancer treatment; therefore, eliminating any systemic side effects associated with treatment.

Procedures: Participating dogs will be anesthetized for the biopsy procedure and viral infusion of the brain tumor.  
Immediately following these procedures, the dog will receive an MRI scan.  Once the scan is completed, the dog will
remain hospitalized at WSU-VTH for at least five days for routine neurologic monitoring.  Two to six weeks after the viral
infusion, the dog will return to WSU-VTH to either begin taking a drug called 5-FC or undergo surgical removal of the
brain tumor and then begin taking 5-FC.  For the next six months, participating dogs will need to return to WSU-VTH every
eight weeks for a neurologic exam, blood work and an MRI.

Benefits: This form of viral gene therapy may be effective in controlling the growth of canine brain tumors and may result
in a longer survival time.  The study will cover the costs of the brain biopsy procedure, viral infusions, brain tumor removal
surgery if indicated, 5-FC, routine intensive care unit monitoring, blood work and MRI scans (approximate value: $10,000).

Owners are responsible for the costs of additional hospitalization, medications and procedures associated with
unforeseen complications.  In addition, to remain in the study, owners are required to bring their dogs back to WSU-VTH
two to six weeks after viral infusion and then every eight weeks for the following six months.
PET CANCER CENTER
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Last updated 02/18/2017
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