Non-Small Cell Lung CancerPhase 1/2SMC4692NCT00828022
Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing attenuated measles vaccine in people with Non-Small Cell Lung Cancer and Measles, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Measles
- What is being tested?
- attenuated measles vaccine
- Type of treatment
- Vaccines
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in remission after first-line chemotherapy
Who cannot join
- Progressive disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Oncology, Soroka Medical Center
Beersheba, 84101
Samuel Ariad, MD
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer, Measles
- Being tested
- attenuated measles vaccine
- Keywords
- measles-positive NSCLC, measles vaccine, consolidation, Stage 3B with pleural effusion or stage 4 non-small cell lung cancer in remission
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attenuated measles vaccineBiological
4-week apart, two vaccines starting 4 weeks after last chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-years
Secondary outcomes (1)
To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828022
- Sponsor's protocol ID
- sor469208ctil
- Acronym
- SMC4692
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2009
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00828022
- Acronym / sponsor ID
- SMC4692 / sor469208ctil
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in remission after first-line chemotherapy
Key exclusion criteria (1 listed)
- Progressive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attenuated measles vaccine4-week apart, two vaccines starting 4 weeks after last chemotherapy | Biological | – |
Primary outcome
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
1 secondary outcome
To evaluate additional measures of efficacy, safety, and disease/treatment-related symptoms.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing attenuated measles vaccine in people with Non-Small Cell Lung Cancer and Measles, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Ariad, MD (972-8-6400537, ariad@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.