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A Trial of JX-594 in Refractory Colorectal Carcinoma

NCT01469611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-02-17

No results posted yet for this study

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.

Conditions

  • Colorectal Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Young suk park, MD · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-10-31
Completion
2015-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01469611 on ClinicalTrials.gov