Clinical trial NCT00442754: Dendritic Cells in Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: dendritic cell
tumor vaccine
NSCLC
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2007-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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). 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.


Primary outcomes:
measure: Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev University Hospital
Study officials:
affiliation: Dept of Oncology, herlev university hospital
name: anders mellemgaard, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: