Clinical trial · Interventional
Immunization With Autologous Dendritic Cells and Tumor Lysates in Melanoma Patients
Phase I/II Trial In Stage III/IV Malignant Melanoma Using Autologous Dendritic Cells Loaded With Tumor Cell Lysates And Low Doses Of Proleukin
- 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)
Implementing this protocol has its ethical justification in that patients with metastatic melanoma, once tumor invasion has reached beyond the lymph node barrier, cannot possibly be treated satisfactorily with traditional surgery methods, radiotherapy, or conventional available chemotherapy. The disseminated tumor is refractory to all standard treatments. Almost 100% of patients who develop distant metastases will die from their disease, either from complications or cachexia. Therefore, immunotherapy based on immunological stimulation with immunocompetent dendritic cells, added to immunological reinforcement with IL-2, can, according to the evidence emanating from ongoing clinical protocols, produce a prolongation of survival with better quality and, in some cases, with partial or total regression of the tumor. General objective: It is to study the clinical and immunological response of patients treated with vaccines based on autologous dendritic cells loaded with tumor antigens, derived from allogeneic melanoma extracts, in combination or not, with intercalated low doses of recombinant human interleukin 2 (rhIL2) PROLEUKIN ® (aldesleukin). MAIN SPECIFIC OBJECTIVE: - SAFETY: Safety in administering dendritic cell preparation; local and systemic toxicity estimation. Determination of adverse reactions such as fever, nausea, allergy, neurological and cardiovascular symptoms. Local toxicity in the administration area. - MEASUREMENT OF THE IMMUNE RESPONSE: Based on in vivo and in vitro parameters: - In vivo response: Measure the type IV Delayed Hypersensitivity (DTH) response. It consists of a crossover test in which the response is compared to tissue interaction in vivo between dendritic cells sensitized with tumor extracts and their respective control unloaded dendritic cells. - In vitro response: ELISPOT assays, measurement of IFN-γ gamma production in peripheral blood of treated patients. Compare the specific immune response after each cycle of therapy through measurement of IFN-γ production by tumor-specific CTL. Cytotoxic radioactive chromium release assays to measure anti-tumor response mediated by CTL and NK. ELISA assays for quantifying cytokines (IFN-γ, IL-10) in patient serum after each cycle of therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Malignant Melanoma of Skin AJCC V6 | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Malignant Melanoma of Skin | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAPCells vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAPCells
- description
- Patients are immunized with four doses of TAPCells (20x106), days 0, 10, 20, and 50 complemented with low doses 2·4×106 IU/m2 rhIL-2 (Proleukin®) (Chiron Emeryville, CA, USA), injected s.c. days 2, 3, and 4 after a second, third, and fourth vaccination.
- interventionNames
- Biological: TAPCells vaccine
Primary outcomes (10)
- measure
- Incidence of treatment-emergent adverse events [safety and tolerability]
- timeFrame
- Every four weeks the first year after treatment. Every two months during the second year after treatment.
- description
- Safety in administering dendritic cell preparations; Toxicity will be evaluated during every immunization and DTH test, using the NCI Common Terminology Criteria for Adverse Events Cancer Therapy Evaluation Program (CTCAE, Bethesda, MD, USA) v.3.0. In addition, patients will have a 24-h emergency phone number to report adverse events. Local and systemic toxicity estimation will be evaluated.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed melanoma of the skin: Breslow, Clark, histological type. Location of the primary, clinical, or pathological regional status. * Complete staging demonstrating the presence of distant metastases, either visceral or in soft tissues or bone tissue: Brain, Lung, Abdomen, and Pelvis CT and bone scintigraphy. * Objectively measurable disease by clinical or radiological means * Karnofsky's Performance Status is more significant than 70% * Life expectancy greater than three months * Patients over 18 years old * Informed consent from the patient to participate in the protocol Exclusion Criteria: * Age greater than or equal to 65 years * Ongoing active infections, including viral immunodeficiency * Previous chemotherapy within less than two months * Concomitant malignant tumors (e.g., Chronic Lymphocytic Leukemia, etc.) * Uncontrolled concomitant diseases (Hypertension, unstable Diabetes mellitus, renal diseases requiring dialysis) * Situations or conditions requiring urgent surgical intervention, such as intestinal obstruction due to metastasis * Pregnancy or lactation * Concurrent participation in other therapeutic research protocols * Any condition that compromises the objectives of this study. Removal Criteria from the Study: * By the patient's decision to discontinue the study. * Intolerable adverse reactions, according to WHO Criteria Grading Toxicities * Intercurrent illness that may compromise the patient's life or interfere with the treatment study evaluation * Requirements for concomitant medication that may interfere with study results. * Failure to complete the study entirely * Failure to follow up on the patient.
References
Publications (5)
- BACKGROUNDAguilera R, Saffie C, Tittarelli A, Gonzalez FE, Ramirez M, Reyes D, Pereda C, Hevia D, Garcia T, Salazar L, Ferreira A, Hermoso M, Mendoza-Naranjo A, Ferrada C, Garrido P, Lopez MN, Salazar-Onfray F. Heat-shock induction of tumor-derived danger signals mediates rapid monocyte differentiation into clinically effective dendritic cells. Clin Cancer Res. 2011 Apr 15;17(8):2474-83. doi: 10.1158/1078-0432.CCR-10-2384. Epub 2011 Feb 3. PMID 21292818
- BACKGROUNDDuran-Aniotz C, Segal G, Salazar L, Pereda C, Falcon C, Tempio F, Aguilera R, Gonzalez R, Perez C, Tittarelli A, Catalan D, Nervi B, Larrondo M, Salazar-Onfray F, Lopez MN. The immunological response and post-treatment survival of DC-vaccinated melanoma patients are associated with increased Th1/Th17 and reduced Th3 cytokine responses. Cancer Immunol Immunother. 2013 Apr;62(4):761-72. doi: 10.1007/s00262-012-1377-3. Epub 2012 Dec 15. PMID 23242374
- BACKGROUNDTittarelli A, Gonzalez FE, Pereda C, Mora G, Munoz L, Saffie C, Garcia T, Diaz D, Falcon C, Hermoso M, Lopez MN, Salazar-Onfray F. Toll-like receptor 4 gene polymorphism influences dendritic cell in vitro function and clinical outcomes in vaccinated melanoma patients. Cancer Immunol Immunother. 2012 Nov;61(11):2067-77. doi: 10.1007/s00262-012-1268-7. Epub 2012 May 3. PMID 22552381
- BACKGROUNDGarcia-Salum T, Villablanca A, Matthaus F, Tittarelli A, Baeza M, Pereda C, Gleisner MA, Gonzalez FE, Lopez MN, Hoheisel JD, Norgauer J, Gebicke-Haerter PJ, Salazar-Onfray F. Molecular signatures associated with tumor-specific immune response in melanoma patients treated with dendritic cell-based immunotherapy. Oncotarget. 2018 Mar 30;9(24):17014-17027. doi: 10.18632/oncotarget.24795. eCollection 2018 Mar 30. PMID 29682201
- RESULTLopez MN, Pereda C, Segal G, Munoz L, Aguilera R, Gonzalez FE, Escobar A, Ginesta A, Reyes D, Gonzalez R, Mendoza-Naranjo A, Larrondo M, Compan A, Ferrada C, Salazar-Onfray F. Prolonged survival of dendritic cell-vaccinated melanoma patients correlates with tumor-specific delayed type IV hypersensitivity response and reduction of tumor growth factor beta-expressing T cells. J Clin Oncol. 2009 Feb 20;27(6):945-52. doi: 10.1200/JCO.2008.18.0794. Epub 2009 Jan 12.