- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197912
Dendritic Cell Based Therapy of Malignant Melanoma
Vaccination With Autologous Dendritic Cells Pulsed With Tumor Antigens for Treatment of Patients With Malignant Melanoma. Phase I/II Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Herlev, Denmark, 2970
- Department of Oncology, Copenhagen University Hospital, Herlev
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary aim of the study is to evaluate tolerability and safety of the treatment
Time Frame: weekly the first four weeks thereafter biweekly
|
weekly the first four weeks thereafter biweekly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary aims: evaluation of treatment induced immune response and clinical response.
Time Frame: after 8 and 16 weeks
|
after 8 and 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Inge Marie Svane, MD, PHD, Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2760 Herlev, Denmark
Publications and helpful links
General Publications
- Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.
- Ellebaek E, Engell-Noerregaard L, Iversen TZ, Froesig TM, Munir S, Hadrup SR, Andersen MH, Svane IM. Metastatic melanoma patients treated with dendritic cell vaccination, Interleukin-2 and metronomic cyclophosphamide: results from a phase II trial. Cancer Immunol Immunother. 2012 Oct;61(10):1791-804. doi: 10.1007/s00262-012-1242-4. Epub 2012 Mar 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclooxygenase 2 Inhibitors
- Cyclophosphamide
- Celecoxib
- Interleukin-2
Other Study ID Numbers
- MM0413
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Melanoma
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma (Locally Advanced) | Stage IIC Melanoma (Locally Advanced) | Stage IV Melanoma (Limited, Resectable)United States
-
BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
-
Regeneron PharmaceuticalsBristol-Myers SquibbCompletedMelanoma | Metastatic Melanoma | Unresectable Melanoma | Advanced MelanomaUnited States
-
Regeneron PharmaceuticalsBristol-Myers SquibbActive, not recruitingMelanoma | Metastatic Melanoma | Unresectable Melanoma | Advanced MelanomaUnited States
-
MorphotekTerminatedMelanoma | Metastatic Melanoma | Advanced Melanoma | Malignant Metastatic MelanomaUnited States
-
Millennium Pharmaceuticals, Inc.CompletedAdvanced Metastatic Melanoma | Advanced Non-hematologic MalignanciesUnited States
-
University of Colorado, DenverMerck Sharp & Dohme LLCActive, not recruitingStage IV Melanoma | Advanced Melanoma | Stage III MelanomaUnited States
-
Azienda Ospedaliera di PerugiaNot yet recruitingAdvanced Melanoma | Early MelanomaItaly, Sweden, France, Germany, Netherlands, Poland, Spain
-
Cancer Trials IrelandCompletedMetastatic Melanoma | Advanced MelanomaIreland
-
Bristol-Myers SquibbCompletedMetastatic Melanoma | Advanced MelanomaUnited States, Netherlands, Spain
Clinical Trials on tumor antigen loaded autologous dendritic cells
-
Inge Marie SvaneCompleted
-
Erasmus Medical CenterCompleted
-
University Hospital ErlangenUniversity Hospital, Essen; University Hospital Tuebingen; Universitätsklinikum... and other collaboratorsActive, not recruiting
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)UnknownMelanoma (Skin)United States
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Completed
-
University Hospital, AntwerpCompletedAcute Myeloid Leukemia (AML)Belgium
-
Herlev HospitalTerminated
-
Istituto Scientifico Romagnolo per lo Studio e...RecruitingStage IV Colorectal Cancer | Curative ResectionItaly
-
National Center for Research Resources (NCRR)Duke UniversityUnknown
-
Safe Save Medical Cell Sciences & Technology Co...UnknownGlioblastoma MultiformeTaiwan