Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2006-12-31
2009-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Allogeneic Tumour Lysate (MelCancerVac)
subcutaneaus, /once weekly /4 wks then /4 weekly
Eligibility Criteria
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18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Herlev Hospital
OTHER
Responsible Party
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Dandrit biotech
Principal Investigators
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anders mellemgaard, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Oncology, herlev university hospital
Locations
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Herlev University Hospital
Copenhagen, , Denmark
Countries
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Other Identifiers
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Dendric cells in lungcancer
Identifier Type: -
Identifier Source: org_study_id
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