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Phase II Study of Lucanix™ in Patients With Stages II-IV Non-Small Cell Lung Cancer

NCT01058785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2010-07-29

No results posted yet for this study

Summary

In this Phase II clinical trial the investigators will use four human non-small cell lung cancer cell lines that have been previously established in tissue culture laboratory. The investigators will gene modify these tumor cells in the laboratory to block their TGF-beta secretion. The investigators will inject the genetically engineered cells as vaccines in patients with stages II to IV non-small cell lung cancer. Our rationale for using other people's tumor cells is that lung tumor cell lines belonging to different people have been shown to share common characteristics that are recognized by non-self immune systems.

Conditions

  • Lung Neoplasm
  • Carcinoma, Bronchogenic

Interventions

BIOLOGICAL

Lucanix

Monthly intradermal injections of four irradiated allogeneic TGF-beta2 antisense gene modified NSCLC cell lines. Patients are randomized to receive either 12,500,000, 25,000,000 or 50,000,000 cells per injection for up to 16 injections.

Sponsors & Collaborators

  • NovaRx Corporation

    lead INDUSTRY

Principal Investigators

  • Habib Fakhrai, PhD · NovaRx Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States

Study Locations

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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 NCT01058785 on ClinicalTrials.gov