Clinical trial · Interventional
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
NCT00197912CI-TRIAL-00003388completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tumor antigen loaded autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary aim of the study is to evaluate tolerability and safety of the treatment
- timeFrame
- weekly the first four weeks thereafter biweekly
Secondary outcomes (1)
- measure
- Secondary aims: evaluation of treatment induced immune response and clinical response.
- timeFrame
- after 8 and 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDSvane 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. PMID 14985857
- DERIVEDEllebaek 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. PMID 22426890