Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
1. Patients included in this protocol must carry one or more of the following tissue
typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that
50% of melanoma patients will be eligible.
2. Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma
3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal
of lymph nodes.
4. Metastatic melanoma AJCC stage IV, completely resected.
5. Non cutaneous malignant melanoma of respective stages including uveal and mucosal
6. Melanoma can be of either mutant or wild-type B-RAF.
7. Karnofsky performance status over 80 (Normal activity with effort).
8. No active cardio-respiratory disease.
9. Hematocrit over 25% and WBC over 3000.
10. Informed consent of the patient.
1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior
to protocol administration.
2. Active brain metastases requiring cortico-steroids.
3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early
stage prostate cancer).
4. Active serious infection.
5. Allergy to penicillin.
6. Patient's wish to withdraw from the study at any stage.