drugset / Trial / NCT00197912
Dendritic Cell Based Therapy of Malignant Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-09
- Primary completion
- 2010-04
- Completion
- 2010-04
Publications
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DC vaccine | Vaccine | 5e+06 cells | Intravenous |
| Background | Celecoxib | Other / unclassified | 200 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Background | aldesleukin | Protein / enzyme biologic | 2e+06 iu | Subcutaneous |