Status:
WITHDRAWN
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients
Lead Sponsor:
Hadassah Medical Organization
Conditions:
High Risk HLA-A2+ Melanoma
Metastatic Disease
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
Brief Summary
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in p...
Eligibility Criteria
Inclusion
- 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.
- Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
- Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
- Metastatic melanoma AJCC stage IV, completely resected.
- Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
- Melanoma can be of either mutant or wild-type B-RAF.
- Karnofsky performance status over 80 (Normal activity with effort).
- No active cardio-respiratory disease.
- Hematocrit over 25% and WBC over 3000.
- Informed consent of the patient.
Exclusion
- Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
- Active brain metastases requiring cortico-steroids.
- Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
- Active serious infection.
- Allergy to penicillin.
- Patient's wish to withdraw from the study at any stage.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01861938
Start Date
March 1 2017
End Date
March 1 2019
Last Update
October 2 2025
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