A Pilot Phase 2 Trial of the Immunogenicity, and Safety o... | NCT00655161

Studies
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

NCT00655161

Sponsor

GlobeImmune

Status

Completed

Last Update Posted

Jan 29, 2014Estimated

Enrollment

24Actual

Phase

Phase 2

Conditions

NSCLC

Interventions

GI-4000

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 2, 2008

First Submission Date that Met QC Criteria

Apr 8, 2008

First Posted Date

Apr 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2014

Last Update Posted Date

Jan 29, 2014Estimated

Name	Class
Memorial Sloan Kettering Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GI-4000	Biological	subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence

Measure	Description	Time Frame
Immune response to GI-4000		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jamie Chaft, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan-Kettering Cancer Center		New York	New York	10021	United States

Type	Date	Date Unknown
Release	Jun 17, 2014
Reset	Jul 16, 2014

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Jun 17, 2014

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.