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COMPLETED
NCT01394939
PHASE1/PHASE2

Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

Sponsor: Jennerex Biotherapeutics

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2012-01

Completion Date

2015-10

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

JX-594

Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

DRUG

Irinotecan

180 mg/m2 IV every 2 weeks.

Locations (11)

Mayo Clinic

Scottsdale, Arizona, United States

UCSD Moores Cancer Center

La Jolla, California, United States

Billings Clinic Cancer Center

Billings, Montana, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Ottawa Hospital and Research Institute (OHRI)

Ottawa, Ontario, Canada

Hôpital Saint Antoine

Paris, France

Hôpital Hautepierre

Strasbourg, France

Institut Claudius Regaud

Toulouse, France