A Phase 1/2a Dose-escalation Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximally-tolerated dose (MTD) or maximum feasible dose (MFD) of JX-594 administered by 5 IV infusions alone and in combination with irinotecan
Any of the following treatment related adverse events: Grade 4 toxicity (except isolated G4 lymphopenia lasting ≤ 7 days), Grade 3 or 4 hypotension, disseminated intravascular coagulation (DIC) or allergic reaction/hypersensitivity, Grade 3 non-hematologic toxicity persisting for > 7 days (except for transaminitis (increase in AST and/or ALT), which may last > 7 days if total bilirubin is normal or Grade 1 or flu-like symptoms that respond to standard treatments), or Grade 3 hematologic toxicity persisting for > 7 days.
DLTs evaluated until Week 5/Day36
James Burke, MD
United States: Food and Drug Administration
|Billings Clinic Cancer Center||Billings, Montana 59107-5100|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|The Ohio State University||Columbus, Ohio 43210|
|Mayo Clinic||Scottsdale, Arizona|
|Gabrail Cancer Center||Canton, Ohio 44718|
|UCSD Moores Cancer Center||La Jolla, California 93093|