Status:
COMPLETED
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
Lead Sponsor:
GlobeImmune
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
NSCLC is the deadliest form of human cancer, killing approximately 150,000 people a year in the United States. The best treatment for NSCLC is surgical resection. For patients with inoperable or unres...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00655161
Start Date
April 1 2008
End Date
November 1 2013
Last Update
January 29 2014
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021