NCT01469611

A Trial of JX-594 in Refractory Colorectal Carcinoma

A Phase 1b Dose Escalation Study of JX-594 (Thymidine Kinase-Inactivated Vaccinia Virus Plus GM-CSF) Administered by Biweekly (Every Two Weeks) Intravenous Infusion in Patients With Metastatic, Refractory Colorectal Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion. * determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by biweekly IV infusion.

Detailed description

This is a Phase 1b, open-label, dose-escalation trial in patients with advanced colorectal carcinoma (CRC) that have failed both oxaliplatin based and irinotecan based prior chemotherapy regimens for metastatic disease. Patients will receive treatment at one of three dose levels in a sequential dose-escalating design. Three patients will be treated at each dose level unless a dose-limiting toxicity (DLT) is observed. Enrollment will proceed to the next dose level if 0 of 3 patients experiences a DLT; if one of the first 3 patients experiences a DLT, additional patients will be enrolled until a second patient experiences a DLT (which defines the toxic dose) or until six total patients have been treated at that dose level, whichever comes first. If a second DLT is not experienced within that cohort, dose escalation may continue. Patients will be enrolled a minimum of 14 days after the first treatment of the immediately preceding patient for the first patient in any cohort or all remaining patients in a cohort with DLT. If 2 DLTs are observed within a cohort, enrollment into the cohort will cease and the dose level immediately preceding that dose will be determined to be the MTD. Regulatory Authorities and the IRB will be notified as required if any patient dies within 28 days of product administration due to a serious and unexpected ADR that is determined by the Investigator to be possibly or probably related to JX-594. Once the MTD and/or MFD is defined, an additional 3-6 patients may be enrolled at that dose level. Note: once the MTD and/or MFD is defined, treatment of additional patients at this dose level will no longer require inter-patient delays of 14 days.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	JX-594	Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL.

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-10-01
• Completion: 2015-01-01
• First posted: 2011-11-10
• Last updated: 2017-02-17

Locations

1 site across 1 country: South Korea