A Pilot 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

This study is currently recruiting participants.

Verified by GlobeImmune, April 2008

Sponsors and Collaborators:	GlobeImmune Memorial Sloan-Kettering Cancer Center
Information provided by:	GlobeImmune
ClinicalTrials.gov Identifier:	NCT00655161

Purpose

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.

Condition	Intervention	Phase
NSCLC	Biological: GI-4000	Phase I

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot 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

Further study details as provided by GlobeImmune:

Primary Outcome Measures:

Immune response to GI-4000 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655161

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Christopher Azzoli, M.D. 212-639-2131 cazzoli@mskcc.org
Principal Investigator: Christopher Azzoli, M.D.

Sponsors and Collaborators

GlobeImmune

Memorial Sloan-Kettering Cancer Center

More Information

Sponsor's website This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial SLoan-Kettering Cancer Center ( Christopher Azzoli, M.D. )
Study ID Numbers:	GI-4000-03
Study First Received:	April 2, 2008
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00655161
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlobeImmune:

NSCLC
Cancer Immunotherapy

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009