Full Text View
Tabular View
No Study Results Posted
Related Studies
Dendritic Cells in Lung Cancer
This study is currently recruiting participants.
Verified by Herlev Hospital, February 2007
First Received: March 1, 2007   No Changes Posted
Sponsors and Collaborators: Herlev Hospital
University of Copenhagen
Information provided by: Herlev Hospital
ClinicalTrials.gov Identifier: NCT00442754
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer
Biological: Allogeneic Tumour Lysate (MelCancerVac)
Phase II

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Herlev Hospital:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 50
Study Start Date: December 2006
Estimated Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Patients with inoperable locoregional or advanced NSCLC irrespective of histological subtype where chemotherapeutical treatment options are depleted.
  • Histologically or cytologically confirmed diagnosis
  • Access to histological tumour material from the patient
  • Performance <2 (Eastern Cooperative Oncology Group (ECOG) performance scale)
  • Expected remaining lifetime of min. 12 weeks
  • Inclusion shall take place at least 4 weeks after the latest dosage of chemotherapy.
  • Inclusion shall take place at least 4 weeks after the latest radiation therapy.
  • Inclusion shall take place at least 1 week after latest treatment with immunosuppressing drugs (incl. Prednisolone).
  • Patients who have recovered (CTC<1) from the acute toxicity in connection with any other previous treatment.
  • Granulocytes ≥1.5 x 109/L and thrombocytes >100 x 109/L
  • Serum bilirubin ≤1.5 x ULN
  • AST and/or ALT ≤2 x ULN (or ≤5 x ULN if hepatic metastases)
  • Liver and kidneys <2 x ULN – however, LDH can be increased without restrictions.
  • Serum creatinine ≤1.5 x ULN or creatinine clearance ≥60 ml/min.
  • Women of childbearing potential must use safe contraception.
  • At least one measurable parameter after RECIST criteria
  • Signed informed consent form after oral as well as written information.
  • The patient must be willing to use the adjuvants (celecoxib 200 mg/day, Iron C 100 mg/day, Aldara cream 5% and IL-2) from the time of the first vaccination and to the completion of the study unless side effects will necessitate withdrawal.

Exclusion Criteria:

  • Malign disease during the latest five years.
  • Any form of unstable systemic disease, including acute infection and level 4 hypertension, unstable angina, cardiac disease as well as liver and kidney diseases and metabolic diseases.
  • Patients who can not take oral drugs or have previously had surgery affecting food uptake.
  • Patients with present or previous ulcus disease or dyspeptic genes within three months. However, patients taking antacids, H2 blockers or PPI can be included
  • Serious medical disease, e.g. severe asthma, poorly controlled cardiovascular disease
  • Acute/chronic infection of HIV, hepatitis, tuberculosis among other things
  • Serious allergy or previous anaphylactic reactions
  • Autoimmune diseases (e.g. autoimmune neutropenia/thrombocytopenia or haemolytic anaemia, systemic lupus erythematosus, Sjøgren’s disease, sclerodermia, myasthenia gravis, Goodpasture’s syndrome, Addison’s disease, Hashimoto’s thyroiditis, active Graves’ disease)
  • Pregnant and lactating women
  • Mental diseases which can affect the patients’ compliance of the study according to the opinion of the investigator.
  • Known hypersensitivity to the substances of the adjuvants (celecoxib, Iron C, Aldara cream, “patches”, IL-2).
  • Concomitant treatment of immunosuppressing drugs (incl. Prednisolone)
  • Concomitant treatment with other experimental substances
  • Concomitant, other systemic anticancer treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442754

Contacts
Contact: anders mellemgaard, MD PhD andmel01@heh.regionh.dk

Locations
Denmark
Herlev University Hospital Recruiting
Copenhagen, Denmark, DK-2730 Herlev
Principal Investigator: anders mellemgaard, MD PhD            
Sponsors and Collaborators
Herlev Hospital
University of Copenhagen
Investigators
Principal Investigator: anders mellemgaard, MD PhD Dept of Oncology, herlev university hospital
  More Information

No publications provided

Study ID Numbers: Dendric cells in lungcancer
Study First Received: March 1, 2007
Last Updated: March 1, 2007
ClinicalTrials.gov Identifier: NCT00442754     History of Changes
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
dendritic cell
tumor vaccine
NSCLC

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009