Back to results

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

Primary Purpose

NSCLC

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GI-4000

About this trial

This is an interventional treatment trial for NSCLC focused on measuring NSCLC, Cancer Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Immune response to GI-4000

Secondary Outcome Measures

Full Information

NCT ID

NCT00655161

First Posted

April 2, 2008

Last Updated

January 28, 2014

Sponsor

GlobeImmune

Collaborators

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00655161

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlobeImmune

Collaborators

Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC

Keywords

NSCLC, Cancer Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

GI-4000

Intervention Description

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

Primary Outcome Measure Information:

Title

Immune response to GI-4000

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jamie Chaft, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Learn more about this trial

We'll reach out to this number within 24 hrs