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

January 28, 2014 updated by: GlobeImmune

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune response to GI-4000
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlobeImmune

Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Jamie Chaft, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-4000-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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