Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01394939|
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma CRC||Biological: JX-594 Drug: Irinotecan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||October 2015|
Experimental: Single Agent
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)Drug: Irinotecan
180 mg/m2 IV every 2 weeks.
- 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 [ Time Frame: DLTs evaluated until Week 5/Day36 ]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.
- Determine the safety of JX-594 administered by 5 IV infusions followed by up to 3 IV JX-594 boosts alone and in combination with irinotecan [ Time Frame: 28 days after last dose of JX-594 IV. ]Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
- Determine radiographic response rate of patients enrolled in the Phase 2a portion of the study [ Time Frame: Scans Every 8 weeks until Progression ]RECIST and Choi response criteria
- Progression Free Disease [ Time Frame: CT scans every 8 weeks until Progression ]CT scans performed every 8 weeks until documented tumor progression.
- Survival [ Time Frame: Monthly until Death or Lost-to-Followup ]Compare overall survival time of patients treated with JX-594 alone or in combination with Irinotecan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394939
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093|
|United States, Montana|
|Billings Clinic Cancer Center|
|Billings, Montana, United States, 59101|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599-1651|
|United States, Ohio|
|Gabrail Cancer Center|
|Canton, Ohio, United States|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Ottawa Hospital and Research Institute (OHRI)|
|Ottawa, Ontario, Canada, K1H 8L6|
|Hôpital Saint Antoine|
|Paris, France, 75012|
|Strasbourg, France, 67098|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Study Director:||James Burke, MD||Jennerex Biotherapeutics|
|Principal Investigator:||Derek Jonker, MD||Ottawa Hospital and Research Institute|