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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 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency |
dendritic cell cancervaccine cyclophosphamide melanoma |
Celecoxib Immunologic Factors Cyclophosphamide Immunosuppressive Agents Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Analgesics, Non-Narcotic Interleukin-2 |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Peripheral Nervous System Agents Analgesics Antineoplastic Agents, Alkylating Nevus Antirheumatic Agents Alkylating Agents |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Cyclophosphamide Melanoma Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Analgesics Alkylating Agents |
Neoplasms by Histologic Type Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Interleukin-2 Analgesics, Non-Narcotic Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |