Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer

Phase 1

• Conditions: Non-Small Cell Lung Cancer; Measles

• Registration Number: NCT00828022
• Lead Sponsor: Soroka University Medical Center

Brief Summary

The objectives of the study are to assess the efficacy and safety of live, attenuated measles vaccine as consolidation therapy in patients with measles-positive, non-small cell lung cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors in remission.

Detailed Description

This is a single-institution, non-randomized phase 1/2 study in patients with locally-advanced or metastatic NSCLC in remission after receiving standard systemic chemotherapy of four cycles of combination chemotherapy consisting of four cycles of cisplatin combined with vinorelbine.

Study Timeline

• Status Verified: 2009-01
• Study First Submitted: 2009-01-22
• Study First Submitted QC: 2009-01-22
• Last Update Submitted: 2009-01-22
• Study First Posted: 2009-01-23
• Last Update Posted: 2009-01-23
• Study Start: 2009-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients in remission after first-line chemotherapy

Exclusion Criteria

• Progressive disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess progression-free survival (PFS) and overall survival (OS) in patients with NSCLC in remission receiving subcutaneous live-attenuated measles virus vaccine as consolidation therapy in patients with measles-positive tumors.	2-years

Secondary Outcome Measures

Name	Time	Method
To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms.	2 years

Trial Locations

Locations (1)

Department of Oncology, Soroka Medical Center; 🇮🇱 Beer Sheva, Israel