Non Small Cell Lung CancerPhase 2NCT00442754
Dendritic Cells in Lung Cancer
A Phase 2 study testing Allogeneic Tumour Lysate (MelCancerVac) in people with Non Small Cell Lung Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Allogeneic Tumour Lysate (MelCancerVac)
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2006to Nov 2009
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccination With Autologous Dendritic Cells Pulsed With Allogeneic Tumour Lysate (MelCancerVac) for the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. A Phase II Study
Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The treatment aims at boosting the patient's specific immune system against the cancer cells.
Read the detailed description
Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The treatment aims at boosting the patient's specific immune system against the cancer cells.
Patients with disseminated, inoperable NSCLC after chemotherapy and patients not wanting chemotherapy for which no other systemic treatments can be offered.
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.
Secondary objectives: to estimate the patients' survival time, to estimate response according to RECIST criteria, and to estimate the patients' quality of life during the study period.
The study is designed as an open, phase II, clinical study and will be carried out in accordance with the present protocol, ICH/GCP Guidelines and national, regulatory requirements.
The first patient is expected to be included towards the end of 2006. Inclusion period will continue for 2 years. Follow-up will continue for approx. 6 months prior to reporting.
Fifty patients are planned for inclusion. In case none of the first fourteen (14) evaluable patients will respond, the inclusion and the study will be discontinued.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Allogeneic Tumour Lysate (MelCancerVac)
- Keywords
- dendritic cell, tumor vaccine, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Tumour Lysate (MelCancerVac)Biological
subcutaneaus, /once weekly /4 wks then /4 weekly
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.
Measured: 3 years
Secondary outcomes (1)
Secondary objectives: to estimate the patients' survival time, to estimate response according to RECIST criteria, and to estimate the patients' quality of life during the study period.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionNov 2009
- Study completionNov 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Investigators
- anders mellemgaard, MD PhD, Principal investigator, Dept of Oncology, herlev university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442754
- Sponsor's protocol ID
- Dendric cells in lungcancer
- Status last verified
- Nov 2009
- First submitted
- 1 Mar 2007
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination With Autologous Dendritic Cells Pulsed With Allogeneic Tumour Lysate (MelCancerVac) for the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. A Phase II Study
- ClinicalTrials.gov ID
- NCT00442754
- Acronym / sponsor ID
- Dendric cells in lungcancer
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- dendritic cell, tumor vaccine, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Dec 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Mar 2007 (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.
Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The treatment aims at boosting the patient's specific immune system against the cancer cells.
Detailed description
Vaccination with autologous dendritic cells pulsed with allogeneic melanoma cell lysate (MelCancerVac) in combination with the Cox-2 inhibitor of celecoxib for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC). Adjuvant Aldara cream will be used as adjuvant for induction of inflammation at the injection site, and the lymphocyte growth factor of interleukin-2 (IL-2) will be given as s.c. injection. The treatment aims at boosting the patient's specific immune system against the cancer cells.
Patients with disseminated, inoperable NSCLC after chemotherapy and patients not wanting chemotherapy for which no other systemic treatments can be offered.
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.
Secondary objectives: to estimate the patients' survival time, to estimate response according to RECIST criteria, and to estimate the patients' quality of life during the study period.
The study is designed as an open, phase II, clinical study and will be carried out in accordance with the present protocol, ICH/GCP Guidelines and national, regulatory requirements.
The first patient is expected to be included towards the end of 2006. Inclusion period will continue for 2 years. Follow-up will continue for approx. 6 months prior to reporting.
Fifty patients are planned for inclusion. In case none of the first fourteen (14) evaluable patients will respond, the inclusion and the study will be discontinued.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Allogeneic Tumour Lysate (MelCancerVac)subcutaneaus, /once weekly /4 wks then /4 weekly | Biological | – |
Primary outcome
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.
Time frame: 3 years
1 secondary outcome
Secondary objectives: to estimate the patients' survival time, to estimate response according to RECIST criteria, and to estimate the patients' quality of life during the study period.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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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.
anders mellemgaard, MD PhD principal investigator
Dept of Oncology, herlev university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Tumour Lysate (MelCancerVac) in people with Non Small Cell Lung Cancer, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 20 Mar 2012. 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 Denmark. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro. (time frame: 3 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 20 Mar 2012.