NCT00656123

Study of Colon GVAX and Cyclophosphamide in Patients With Metastatic Colorectal Cancer

A Safety and Feasibility Study of an Allogeneic Colon Cancer Cell Vaccine Administered With a GM-CSF Producing Bystander Cell Line in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and feasibility of vaccination with two irradiated allogeneic colorectal carcinoma cells administered with a GM-CSF producing bystander cell line in sequence with an immunomodulatory dose of Cyclophosphamide

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Colon GVAX	Dose escalation: 1.4x10\^8 to 7x10\^8 cells administered in up to 15 intradermal injections on Day 2 of Cycles 1-4
DRUG	cyclophosphamide	200 mg/m\^2 administered IV on Day 1 of Cycles 1-4

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-08-01
• Completion: 2013-01-01
• First posted: 2008-04-10
• Last updated: 2019-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study