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

Non-Small Cell Lung Cancer Clinical Trial

— SMC4692  

Official title:

A Single-Institution, Open-Label, Single-Arm phase1/2 Study of Measles Vaccine as Consolidation in Patients With Measles Virus-Positive, Stage 3B/4 Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00828022
• Other study ID #: sor469208ctil
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 22, 2009
• Last updated: January 22, 2009
• Start date: March 2009

Study information

• Verified date: January 2009
• Source: Soroka University Medical Center
• Contact: Samuel Ariad, MD
• Phone: 972-8-6400537
• Email: ariad[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients in remission after first-line chemotherapy

Exclusion Criteria:

• Progressive disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Measles
• Non-Small Cell Lung Cancer

Intervention

Biological:
• attenuated measles vaccine
4-week apart, two vaccines starting 4 weeks after last chemotherapy

Locations

Country	Name	City	State
Israel	Department of Oncology, Soroka Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms.		2 years	Yes