NCT01898039

Modified Vaccine for High Risk or Low Residual Melanoma Patients

Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients - Phase I/II Study.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	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.
PROCEDURE	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.
DRUG	Cyclophosphamide	On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.

Timeline

• Start date: 2013-05-01
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2013-07-12
• Last updated: 2025-10-02

Locations

1 site across 1 country: Israel