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Sponsored by: |
Herlev Hospital |
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Information provided by: | Herlev Hospital |
ClinicalTrials.gov Identifier: | NCT00197912 |
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.
Condition | Intervention | Phase |
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Advanced Melanoma |
Biological: tumor antigen loaded autologous dendritic cells |
Phase I Phase II |
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 Tumor Antigens for Treatment of Patients With Malignant Melanoma.Phase I/II Study. |
Estimated Enrollment: | 25 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Inge Marie Svane, MD, PHD | +45 44 88 44 88 ext 82 131 | imsv@heh.regionh.dk |
Denmark | |
Department of Oncology, Copenhagen University Hospital, Herlev | Recruiting |
Herlev, Denmark, 2970 | |
Contact: Inge Marie Svane, MD, PHD +44 88 44 88 ext 82 131 imsv@heh.regionh.dk | |
Sub-Investigator: Poul Geertsen, MD, PHD | |
Sub-Investigator: Eva Ellebæk, MD |
Principal Investigator: | Inge Marie Svane, MD, PHD | Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark |
Responsible Party: | Department of Oncology, Herlev Hospital ( Inge Marie Svane, MD, PhD ) |
Study ID Numbers: | MM0413 |
Study First Received: | September 12, 2005 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00197912 |
Health Authority: | Denmark: Danish Medicines Agency |
dendritic cell cancervaccine cyclophosphamide melanoma |
Neuroectodermal Tumors Celecoxib Aldesleukin Interleukin-2 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Cyclophosphamide Nevus Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Sensory System Agents |
Analgesics, Non-Narcotic Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |