Conditions: Colorectal Carcinoma CRC
Keywords: Vaccinia Vaccinia Virus JX-594 Jennerex Colorectal Carcinoma Colorectal cancer Colon Cancer Rectal Cancer oncolytic virus viral therapy RAS mutant Erbitux failure Oxaliplatin failure FOLFOX failure FOLFIRI failure Irinotecan failure Pexa-Vec
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 52
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

Detailed description:
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)

Arms:
arm 1: JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10\^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29 arm 2: JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.

JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29 arm 3: 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.

JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. arm 4: 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.

JX-594: RAC VAC GM-CSF JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.

Interventions: intervention 1: JX-594 intervention 2: Irinotecan
Intervention descriptions: intervention 1: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) intervention 2: 180 mg/m2 IV every 2 weeks.

Protocol document: