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

Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer (SMC4692)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Soroka University Medical Center. Recruitment status was Not yet recruiting

First Received on January 22, 2009. No Changes Posted

Sponsor:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00828022

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer Measles	Biological: attenuated measles vaccine	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Measles

Drug Information available for: Measles Vaccine

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:

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. [ Time Frame: 2-years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	March 2009

Intervention Details:

4-week apart, two vaccines starting 4 weeks after last chemotherapy

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients in remission after first-line chemotherapy

Exclusion Criteria:

Progressive disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828022

Contacts

Contact: Samuel Ariad, MD

972-8-6400537

ariad@bgu.ac.il

Locations

Israel
Department of Oncology, Soroka Medical Center	Not yet recruiting
Beer Sheva, Israel, 84101
Principal Investigator: Samuel Ariad, MD

Sponsors and Collaborators

Soroka University Medical Center

More Information

No publications provided

Responsible Party:	Prof. Samuel Ariad, Department of Oncology, Soroka Medical Center, Beer Sheva
ClinicalTrials.gov Identifier:	NCT00828022 History of Changes
Other Study ID Numbers:	sor469208ctil
Study First Received:	January 22, 2009
Last Updated:	January 22, 2009
Health Authority:	Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:

measles-positive NSCLC
measles vaccine
consolidation
Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Measles
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012