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Title   Study of REOLYSIN® in Combination With FOLFIRI in Patients With Oxaliplatin Refractory/Intolerant KRAS Mutant Colorectal Cancer
Description   This is a Phase 1 dose-escalation study with three dose levels to determine the maximum tolerated dose of REOLYSIN combined with FOLFIRI.

Reovirus Serotype 3 - Dearing Strain (REOLYSIN) is a naturally occurring, ubiquitous, non-enveloped human reovirus. Reovirus has been shown to replicate selectively in Ras-transformed cells causing cell lysis. Activating mutations in ras or mutation in oncogenes signaling through the ras pathway may occur in as many as 80% of human tumors. The specificity of the reovirus for Ras-transformed cells, coupled with its relatively nonpathogenic nature in humans, makes it an attractive anti-cancer therapy candidate.
Eligibility Criteria   To be eligible for this study, patients must meet several criteria, including but not limited to the following:

* Patient must be 18 Years and older

* Patient must have histologically confirmed cancer of the colon or rectum with radiologically documented and measurable metastases (high CEA alone is insufficient for study entry).

* Patient must have received oxaliplatin (with or without 5-FU or capecitabine) as front-line therapy in the metastatic setting.

* Patient must have a life expectancy of at least 3 months.

* Patient must be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
Principal Investigator   Sanjay Goel, MD
Phone   (718) 904-2488
Contact Email   sgoel@montefiore.org
Post Date   01/07/2011
Protocol Number   10-02-037/West
Status   Recruiting
Current Trial Type   Interventional
Adult Clinical Trial   No
Pediatric Clinical Trial   No