Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers

Summary

Participation Requirements

Description

Background: Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative, and patients frequently succumb to disease recurrence in the ensuing months to year(s) after the operation. Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer little dem...

Background: Resections to remove tumors in the liver, bile ducts and pancreas are rarely curative, and patients frequently succumb to disease recurrence in the ensuing months to year(s) after the operation. Standard adjuvant therapies, which typically begin 6-12 weeks after surgery, offer little demonstrable decreases in the rates of tumor recurrence. The concept and implementation of immediate perioperative therapy has not been evaluated given the serious concerns related to healing and recovery with standard cytotoxic chemotherapy and newer targeted agents. A significant percentage of metastatic colorectal cancers, and primary tumors of the pancreas and bile ducts express Sialyl Lewis, an epitope on the well-established tumor marker, CA 19-9. MVT-5873, a fully human antibody against Sialyl Lewis, has displayed ADCC and CDC in vitro, potentiated chemotherapeutic efficacy in mouse models and demonstrated efficacy in Phase 1 trials of patients with advanced inoperable HPB cancers. MVT-5873 is well tolerated as a single agent; moderate elevations in AST/ALT appear to be dose-limiting. Patients with resectable Sialyl Lewis-expressing cancers represent an ideal population to explore the use of perioperative MVT-5873 given moderate level of CA 19-9 elevations, and the potential for extension of recurrence-free survival. Objectives: Document the safety of perioperative MVT-5873 in patients undergoing pancreas and liver resections. Determine if perioperative MVT-5873 can decrease 1-year recurrence rates for patients with operable CA 19-9-producing cancers. Eligibility: Histologically or cytologically confirmed adenocarcinoma of the Colon (metastatic to liver) Pancreas Bile Ducts (Cholangiocarcinoma) Serum CA19-9 levels greater than the upper limit of normal, but less than 2500. Disease amenable to complete surgical extirpation. Design: -Pre-operative one-time treatment with MVT-5873, resection to remove all demonstrable disease in the liver, bile ducts and pancreas, and continuing MVT-5873 mono-therapy until off treatment criteria are met.

Tracking Information