Phase I/II Trial In Stage III/IV Malignant Melanoma Using Autologous Dendritic Cells Loaded With Tumor Cell Lysates And Low Doses Of Proleukin

UCHD04T2026

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.

2001-01-30

2004-10-09

2004-10-09

Completed

Early phase I

90

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.

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2023-11-30