NCT00828022

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
Last Updated

January 23, 2009

Status Verified

January 1, 2009

First QC Date

January 22, 2009

Last Update Submit

January 22, 2009

Conditions

Non-Small Cell Lung CancerMeasles

Keywords

measles-positive NSCLCmeasles vaccineconsolidationStage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission

Outcome Measures

Primary Outcomes (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.

    2-years

Secondary Outcomes (1)

  • To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms.

    2 years

Interventions

attenuated measles vaccineBIOLOGICAL

4-week apart, two vaccines starting 4 weeks after last chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in remission after first-line chemotherapy

You may not qualify if:

  • Progressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Soroka Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungMeasles

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMorbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Samuel Ariad, MD

CONTACT

972-8-6400537ariad@bgu.ac.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

March 1, 2009

Last Updated

January 23, 2009

Record last verified: 2009-01

Locations

IL(1)