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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-01-29

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

GI-4000

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

Sponsors & Collaborators

Principal Investigators

  • Jamie Chaft, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655161 on ClinicalTrials.gov