Dendritic Cells in Lung Cancer

March 19, 2012 updated by: Herlev Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2730 Herlev
        • Herlev University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: anders mellemgaard, MD PhD, Dept of Oncology, herlev university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

March 1, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (ESTIMATE)

March 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dendric cells in lungcancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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