REO 022: A Multicenter Phase 1 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Irinotecan/Fluorouracil/Leucovorin (FOLFIRI) in Patients with Oxaliplatin Refractory/Intolerant KRAS Mutant Colorectal Cancer

Study Status

Closed to Enrollment

Study Description

The purpose of this study is to determine the highest dose of REOLYSIN® in combination with Irinotecan, Leucovorin and Fluorouracil that can be given to subjects with colon cancer without causing side effects and risks that are too severe and to determine how much Irinotecan and Fluorouracil is stored in your blood and how your body gets rid of Irinotecan and Fluorouracil when combined with REOLYSIN®.

REOLYSIN® is an investigational form of cancer treatment that uses a type of virus called reovirus. This virus is commonly found in natural situations throughout the world (such as ponds and ditches) and is associated with only very minor breathing or stomach upsets in humans. Infection of cancer cells by this virus can slow the cancer lesion growth and kill cancer cells. Tests have already been carried out using REOLYSIN® in humans and few side effects have been seen. It is known that the combination of FOLFIRI can benefit patients with several different tumor types.

In this study a cycle is 14 days. On Day 1 of the first cycle you will receive:

  • Irinotecan as a 90-minute infusion
  • Leucovorin as a separate infusion
  • Fluocorouracil in a bolus injection
  • REOLYSIN infusion
  • A second 46 hour Fluorouracil infusion will be started (you will have a special pump attached so you will be able to to home)

On Days 2, 3, 4 and 5 of the first cycle you will receive:

  • REOLYSIN given over 60 minutes infusion

For Cycle 2, you will receive Irinotecan, Leucovorin and Fluoroucaracil only. You will receive REOLYSIN every other cycle, such as Cycle 3 and Cycle 5, as described for as long as you are in the study.

The length of time on study will depend on how well you tolerate therapy with the treatment combination and how your disease responds to this agent.

Disease Status and/or Stage

Colon Cancer

Sponsor

Oncolytics Biotech, Inc.

Key Eligibility

  • Colon or rectum cancer
  • Has received oxaliplatin as front-line therapy in the metastatic setting; patients who are intolerant to oxaliplatin are eligible
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Allyson Ocean, MD

Contact

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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