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

NSCLC Clinical Trial

Official title:

A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655161
• Other study ID #: GI-4000-03
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2008
• Last updated: January 28, 2014
• Start date: April 2008
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: GlobeImmune
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 unresectable NSCLC chemotherapy and radiation is used as first line therapy. 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. These subjects must also have a ras mutation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Biological:
• GI-4000
subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
GlobeImmune	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response to GI-4000		2 years

External Links

•   Sponsor's website