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Dendritic Cells in Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00442754
First received: March 1, 2007
Last updated: March 19, 2012
Last verified: November 2009

March 1, 2007
March 19, 2012
December 2006
November 2009   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients’ immune system in vivo and in vitro.
Complete list of historical versions of study NCT00442754 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Dendritic Cells in Lung Cancer
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non Small Cell Lung Cancer
Biological: Allogeneic Tumour Lysate (MelCancerVac)
subcutaneaus, /once weekly /4 wks then /4 weekly
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2009
November 2009   (final data collection date for primary outcome measure)
Not Provided
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00442754
Dendric cells in lungcancer
No
Dina rosenberg asmussen, Dandrit biotech
Herlev Hospital
University of Copenhagen
Principal Investigator: anders mellemgaard, MD PhD Dept of Oncology, herlev university hospital
Herlev Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP