Status:
RECRUITING
Modified Vaccine for High Risk or Low Residual Melanoma Patients
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Malignant Melanoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease r...
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 (\>4 mm) or IIc (ulcerated melanoma \>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-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
- 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 \> 80 (Normal activity with effort).
- No active cardio-respiratory disease.
- Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit \>25% and WBC \>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 corticosteroids.
- Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
- Active serious infection.
- Allergy to penicillin.
- Patient's will to withdraw from the study at any stage.
- HIV and chronic hepatitis B and C carrier
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01898039
Start Date
May 1 2013
End Date
April 1 2027
Last Update
October 2 2025
Active Locations (1)
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1
Sharett Institute of Oncology, Hadassah Medical Organization
Jerusalem, Israel, 91120