Modified Vaccine for High Risk or Low Residual Melanoma Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- grade 2-4 adverse events according to CTCEA criteria — Day 1
- monitoring anti-tumor immune response — Day 0
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response. - grade 2-4 adverse events according to CTCEA criteria — Day 28
- grade 2-4 adverse events according to CTCEA criteria — Day 56
- grade 2-4 adverse events according to CTCEA criteria — month 3
- grade 2-4 adverse events according to CTCEA criteria — month 4
- grade 2-4 adverse events according to CTCEA criteria — month 5
- grade 2-4 adverse events according to CTCEA criteria — month 6
- monitoring anti-tumor immune response — Day 28
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response - monitoring anti-tumor immune response — Day 56
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response - monitoring anti-tumor immune response — month 3
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response - monitoring anti-tumor immune response — month 4
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response - monitoring anti-tumor immune response — month 5
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response - monitoring anti-tumor immune response — month 6
Anti-tumor immune response will be measured by delayed type hypersensitivity in vivo and by in vitro lymphocyte response
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Sharett Institute of Oncology, Hadassah Medical Organization | Jerusalem | Israel | Recruiting |
More Hadassah Medical Organization trials in Israel
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01898039 on ClinicalTrials.gov ↗ ← All trials in Israel