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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 2, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJanuary 29, 2014
January 1, 2014
5.6 years
April 2, 2008
January 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune response to GI-4000
2 years
Interventions
subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlobeImmunelead
- Memorial Sloan Kettering Cancer Centercollaborator
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Chaft, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2008
First Posted
April 9, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
January 29, 2014
Record last verified: 2014-01