Colorado Animal Specialty & Emergency (CASE)
Canine Oncology Study for Myc Inhibition Tolerability Trial (COSMyc- IT)
CURRENTLY ENROLLING
SUMMARY OF STUDY:
Myc is one of the most frequently amplified oncogenes in most human cancers and often correlates with aggressiveness of the disease. Many different types of cancer take advantage of this molecular pathway. Inhibition of this pathway may lead to a decrease in tumor size or improvement in overall condition. A novel protein that inactivates Myc has been developed and is currently in human trials.
MYC targeting by OMO-103 in solid tumors: a phase 1 trial
Aberrant or increased MYC expression has been detected in dog cancers, including osteosarcoma, B cell lymphoma, soft tissue sarcoma, mammary tumors, and is likely to be present in many more. This study will evaluate the efficacy and feasibility of administering Omo-103 in dogs with cancer to inform future efficacy studies. The most common side effects in other mammals were infusion reactions. This drug will be given as a slow infusion with premedications to limit these side effects. Other side effects, including gastrointestinal upset, lethargy, and fever, are also possible.
At least 30 dogs will be treated with the Omo-103 peptide delivered IV over 30-45 min weekly for a 28-day period. Some dogs will be selected for additional blood sampling and biopsies and will also receive additional compensation for this added participation.
INCLUSION CRITERIA:
Any dog with a recent diagnosis of cancer
>10 kg (22 lb)
10 dogs enrolled in cohorts 3-5 will be required to have biopsy and additional blood sampling. These dogs will need to have a tumor that can be easily biopsied. These dogs will receive pretreatment and post-treatment biopsies and will also receive additional compensation of $1,500 towards their bill for additional therapy.
EXCLUSION CRITERIA:
Dogs that have received chemotherapy or steroids within 7 days of study entry
Significant heart, liver or kidney disease
No medications or supplements with anticancer properties
FINANCIAL INCENTIVES:
Participating pet owners will receive:
The study will pay for the following costs: All exam fees and diagnostics associated with the study and up to of $3,000 per event. Dogs participating in the pharmacokinetic study will have all costs associated with the two biopsies and additional blood sampling covered by the study and they will receive an additional $1500 hospital credit towards their future care.
WHAT TO EXPECT:
Participating patients will be required to complete standard pre-enrollment screening that involves a physical exam, blood work, and urinalysis. Dogs are seen weekly for infusions for a study duration of 4 weeks. We will use owner histories, physical examination and blood work to determine how well patients tolerate the drug. Blood will be taken at regular intervals to determine the activity of Omo-103 in dogs. We will look for increases in certain immune proteins (called cytokines) that may indicate activity. In a small subset we will also take biopsies from tumor before and after therapy to look for Myc-specific inhibition within cancer cells.
INTERESTED?
Email [email protected]
