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
18 Years
80 Years
Both
Non-Small Cell Lung Cancer, Measles
Trial Information
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
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.
Inclusion Criteria:
- Patients in remission after first-line chemotherapy
Exclusion Criteria:
- Progressive disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
2-years
Safety Issue:
Yes
Authority:
Israel: Ministry of Health
Study ID:
sor469208ctil
NCT ID:
NCT00828022
Start Date:
March 2009
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- Measles
- measles-positive NSCLC
- measles vaccine
- consolidation
- Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Measles
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