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, Phase I	Treatment	Active	18 and over	Other	MM0413 NCT00197912

Trial Description

Summary

The aim of the study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines and Cyclophosphamide can induce a measurable immune response in patients with metastatic malignant melanoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

Further Study Information

Eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. The dendritic cells are generated from leukapheresis products and frozen after antigen loading.

HLA A2 positive patients are treated with PADRE and oncopeptide pulsed DC; p53, survivin and telomerase peptides. HLA A2 negative patients are treated with KLH and tumorlysate pulsed DC; autologous or allogeneic. Each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous DC. Vaccination 1-4 is given weekly and 4-6 at 2-week intervals. Those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. The vaccine is applied by intradermal injection near the inguinal region.

IL-2 2 MIU s.c. day 2-6, Cyclophosphamide (Sendoxan®, Baxter A/S) 50 mg twice a day bi-weekly and 200 mg Celecoxib (Celebra®, Pfizer) daily are used.

Scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility Criteria

Inclusion Criteria:

• Histologically proven progressive metastatic or locally advanced melanoma

• No standard treatment indicated

• Age: > 18

• WHO-Performance Status 0-1

• At least tone measurable tumor lesions according to the RECIST criteria.

• Life expectancy more than 3 months

• Acceptable CBC and blood chemistry results

• Written informed consent

Exclusion Criteria:

• Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin).

• Patients with metastatic disease in the central nervous system (CNS).

• Patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure.

• Patients with acute or chronic infection including HIV, hepatitis and tuberculosis.

• Patients who are pregnant.

• Patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial.

• Patients who receive corticosteroids or other immunosuppressive agents.

• Baseline serum LDH greater than 2.5 times the upper limit of normal.

• Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Trial Contact Information

Trial Lead Organizations/Sponsors

Copenhagen County Herlev University Hospital

Inge Marie Svane, MD, PHD

Principal Investigator

Inge Marie Svane, MD, PHD		Ph: +45 44 88 44 88 Ext.82 131
		Email: imsv@heh.regionh.dk

Denmark
	Herlev
	Copenhagen County Herlev University Hospital
		Inge Marie Svane, MD, PHD	Ph: +44 88 44 88 Ext.82 131
			Email: imsv@heh.regionh.dk
		Poul Geertsen, MD, PHD	Sub-Investigator
		Eva Ellebæk, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00197912
Information obtained from ClinicalTrials.gov on March 18, 2009