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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
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00828022
First received: January 22, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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 1
Phase 2

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:


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:
    Biological: attenuated measles vaccine
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Mononegavirales Infections
Morbillivirus Infections
Neoplasms
Neoplasms by Site
Paramyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014