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Modified Vaccine for High Risk or Low Residual Melanoma Patients
Sponsor: Hadassah Medical Organization
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 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.
Official title: Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients - Phase I/II Study.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2013-05
Completion Date
2027-04
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
A2/4-1BBL melanoma vaccine
On days 14, 35, 56, 77 and 98 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed.
DNP sensititzation
Include brand names, serial numbers and code names, if applicable. Other names are used to improve search results on the ClinicalTrials.gov web site. On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm.
Cyclophosphamide
On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.
Locations (1)
Sharett Institute of Oncology, Hadassah Medical Organization
Jerusalem, Israel