A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation

Completed · Phase 2

Conditions studied: NSCLC

In brief

This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.

Key facts

Study ID

NCT00655161

Run by

GlobeImmune

People needed

24

Starts

2008-04-01

Expected to finish

2013-11-01

Last updated by the study team

2014-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically proven stage I-III NSCLC
• Confirmed product related ras mutation
• ECOG performance status of less than or equal to 2
• greater than or equal to 18 years of age

You may not qualify if…

• History of a previous cancer
• History of splenectomy
• History of Crohns disease or ulcerative colitis
• History of major organ transplantation
• Concurrent or chronic steroid therapy
• History of allergy to yeast
• Presence of an unstable or poorly controlled medical condition
• Pregnant or nursing mothers
• Positive skin test to yeast

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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