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

This study has been completed.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
GlobeImmune
ClinicalTrials.gov Identifier:
NCT00655161
First received: April 2, 2008
Last updated: January 28, 2014
Last verified: January 2014
  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 2

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

Resource links provided by NLM:


Further study details as provided by GlobeImmune:

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

Enrollment: 24
Study Start Date: April 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: GI-4000
    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
New York, New York, United States, 10021
Sponsors and Collaborators
GlobeImmune
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jamie Chaft, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: GlobeImmune
ClinicalTrials.gov Identifier: NCT00655161     History of Changes
Other Study ID Numbers: GI-4000-03
Study First Received: April 2, 2008
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlobeImmune:
NSCLC
Cancer Immunotherapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014