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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GI-4000

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No