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

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ClinicalTrials.gov Identifier: NCT00828022
Recruitment Status : Unknown
Verified January 2009 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 23, 2009
Last Update Posted : January 23, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Measles Biological: attenuated measles vaccine Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Measles


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


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in remission after first-line chemotherapy

Exclusion Criteria:

  • Progressive disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: January 23, 2009
Last Verified: January 2009

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:
Measles
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs