NCT00442754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 20, 2012

Status Verified

November 1, 2009

Enrollment Period

2.9 years

First QC Date

March 1, 2007

Last Update Submit

March 19, 2012

Conditions

Non Small Cell Lung Cancer

Keywords

dendritic celltumor vaccineNSCLC

Outcome Measures

Primary Outcomes (1)

  • Primary objective: to measure the antigen specific immunological reaction between vaccine antigens and the patients' immune system in vivo and in vitro.

    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.

    3 years

Interventions

Allogeneic Tumour Lysate (MelCancerVac)BIOLOGICAL

subcutaneaus, /once weekly /4 wks then /4 weekly

Sponsors & Collaborators

Study Sites (1)

Herlev University Hospital

Copenhagen, DK-2730 Herlev, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • anders mellemgaard, MD PhD

    Dept of Oncology, herlev university hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 20, 2012

Record last verified: 2009-11

Locations

DK(1)