TABLE 3.

Study schedule

	Prestudy (within 2 weeks prior to MO32 administration)	Day 0	Day 1	Day 2	Day 3	Day 14 (+/− 4 days)	Day 28 (+/− 4 days)	Month 3 (+/− 12 days)	Month 6 (+/2 12 days)	Month 9 (+/− 12 days)	Month 12 (+/− 12 days)
Informed consent	×
Inclusion/exclusion criteria	×
Signalment	×
Pregnancy test (serum)	×
Medical history	×
Concurrent meds	×	×	×	×	×	×	×	×	×	×	×
Complete physical exam (with wound assessment Days 1–14)	×		×	×	×	×	×	×	×	×	×
Vital signs	×	×	×	×	×	×	×	×	×	×	×
CBC, c diff, platelets	×			×		×	×	×	×	×	×
Serum chemistries, PT/PTT, INR	×			×		×	×	×	×	×	×
Kynurenine levels (serum)	×			×		×	×	×	×	×	×
EKG	×
CXR (AP and lateral)	×
Urinalysis with micro	×
Adverse event evaluation		×	×	×	×	×	×	×	×	×	×
MRI	×						×	×	×
Neurologic exam	×	×	×	×	×	×	×	×	×	×	×
HSV Ab titer	×					×	×	×	×	×	×
HSV detection (saliva, conjunctival secretions, and/or blood)	×			×	×*	×	×	×	×	×	×
IL-12 detection (serum)	×			×	×	×	×	×	×	×	×
MO32 administration		×
Blood for LTA, Elispot	×			×	×	×	×	×	×	×	×
Blood to be stored for future immune studies	×	×		×	×	×	×	×	×	×	×
Head CT		×
Surgery, catheter placement		×
Levetiracetam (prophylactic AED) daily ×6 weeks beginning prior to Day 0**				×
Indoximod administration, daily ×28 days beginning at Day 0***					×

Ab = antibody; AED = antiepileptic drug; AP = anterior-posterior; CBC = complete blood count; CXR = chest x-ray; INR = international normalized ratio; LTA = light transmission aggregometry; PT = prothrombin time; PTT = partial thromboplastin time.

Modified with permission from Chambers MR, Bentley RT, Crossman DK, Foote JB, Koehler JW, Markert JM, Omar NB, Platt SR, Self DM, Shores A, Sorjonen DC, Waters AM, Yanke AB and Gillespie GY (2020). The One Health Consortium: design of a phase I clinical trial to evaluate M032, a genetically engineered HSV-1 expressing IL-12, in combination with a checkpoint inhibitor in canine patients with sporadic high grade gliomas. Front. Surg. 7:59. Copyright 2020, the Authors. CC BY 4.0 (https://creativecommons.org/licenses/by/4.0/).

^*Blood only.

^**AED discontinued prior to 6 weeks if adverse reaction. After 6 weeks, continuation is at the discretion of attending veterinarian.

^***Stage 2 of trial.