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

January 22, 2009
January 22, 2009
March 2009
Not Provided
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 ]
Same as current
No Changes Posted
To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer
  • Measles
Biological: attenuated measles vaccine
4-week apart, two vaccines starting 4 weeks after last chemotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
Not Provided
Not Provided

Inclusion Criteria:

  • Patients in remission after first-line chemotherapy

Exclusion Criteria:

  • Progressive disease
Both
18 Years to 80 Years
No
Contact: Samuel Ariad, MD 972-8-6400537 ariad@bgu.ac.il
Israel
 
NCT00828022
sor469208ctil
Yes
Prof. Samuel Ariad, Department of Oncology, Soroka Medical Center, Beer Sheva
Soroka University Medical Center
Not Provided
Not Provided
Soroka University Medical Center
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP