RecruitingPhase 1Phase 2NCT01898039

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.


Sponsor

Hadassah Medical Organization

Enrollment

50 participants

Start Date

May 1, 2013

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a modified vaccine approach to help the immune system recognize and fight melanoma (a type of skin cancer) in patients who are at high risk of the cancer coming back or who have a small amount of remaining disease after treatment. **You may be eligible if...** - You have been diagnosed with melanoma that is considered high risk or you have a small amount of remaining disease - You have completed primary treatment and your doctor thinks a vaccine approach may help - You are in generally good health and able to attend regular study visits - You meet specific blood and organ function requirements **You may NOT be eligible if...** - You have active, spreading melanoma throughout your body - You have a weakened immune system or are taking medications that suppress immunity (such as steroids) - You have serious autoimmune conditions (where the immune system attacks the body) - You are pregnant or breastfeeding - You have had prior treatments that would interfere with the vaccine's effectiveness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALA2/4-1BBL 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.

PROCEDUREDNP 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.

DRUGCyclophosphamide

On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.


Locations(1)

Sharett Institute of Oncology, Hadassah Medical Organization

Jerusalem, Israel

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NCT01898039


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