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

Primary Purpose

Non-Small Cell Lung Cancer, Measles

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

attenuated measles vaccine

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring measles-positive NSCLC, measles vaccine, consolidation, Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients in remission after first-line chemotherapy

Exclusion Criteria:

Progressive disease

Sites / Locations

Department of Oncology, Soroka Medical Center

Outcomes

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00828022

First Posted

January 22, 2009

Last Updated

January 22, 2009

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00828022

Brief Title

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

Acronym

SMC4692

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 Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer, Measles

Keywords

measles-positive NSCLC, measles vaccine, consolidation, Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

attenuated measles vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

2-years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients in remission after first-line chemotherapy Exclusion Criteria: Progressive disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Samuel Ariad, MD

Phone

972-8-6400537

ariad@bgu.ac.il

Facility Information:

Facility Name

Department of Oncology, Soroka Medical Center

City

Beer Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samuel Ariad, MD

12. IPD Sharing Statement

Learn more about this trial

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

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