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)

This study is not yet open for participant recruitment.

Verified by Soroka University Medical Center, January 2009

First Received: January 22, 2009 No Changes Posted

Sponsored by:	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:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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
Beer Sheva, Israel, 84101

Sponsors and Collaborators

Soroka University Medical Center

More Information

No publications provided

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

Study placed in the following topic categories:

Thoracic Neoplasms
Virus Diseases
Pleural Effusion
Paramyxoviridae Infections
Respiratory Tract Diseases
Lung Neoplasms

Measles
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
RNA Virus Infections
Paramyxoviridae Infections
Neoplasms by Histologic Type
Morbillivirus Infections
Measles
Carcinoma
Virus Diseases

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Mononegavirales Infections
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009