Status:
COMPLETED
Immunization With Autologous Dendritic Cells and Tumor Lysates in Melanoma Patients
Lead Sponsor:
University of Chile
Conditions:
Stage III Malignant Melanoma of Skin AJCC V6
Stage IV Malignant Melanoma of Skin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 satisfacto...
Detailed Description
Vaccination of Melanoma Patients Using DCs Loaded with Allogeneic Melanoma Extracts. In Chile, this study constitutes the first phase I clinical trial for treating advanced malignant melanoma using d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 30 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2004
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06152367
Start Date
January 30 2001
End Date
October 9 2004
Last Update
November 30 2023
Active Locations (1)
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1
Faculty of Medicine, University of Chile
Santiago, RM, Chile, 8380000