Modified Vaccine for High Risk or Low Residual Melanoma Patients
ConditionMalignant Melanoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHadassah Medical Organization
About this trial
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 recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- A2/4-1BBL melanoma vaccine
- DNP sensititzation
- Cyclophosphamide
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov