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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	Dendric cells in lungcancer NCT00442754

Trial Description

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.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Copenhagen County Herlev University Hospital

anders mellemgaard, MD PhD

Principal Investigator

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

Denmark
	Copenhagen
	Copenhagen County Herlev University Hospital
		anders mellemgaard, MD PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00442754
Information obtained from ClinicalTrials.gov on May 13, 2009