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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
NSCLC

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immune response to GI-4000

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GI-4000-03

NCT ID:

NCT00655161

Start Date:

April 2008

Completion Date:

July 2012

Related Keywords:

  • NSCLC
  • NSCLC
  • Cancer Immunotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021