Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients
|ClinicalTrials.gov Identifier: NCT01861938|
Recruitment Status : Unknown
Verified December 2012 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : May 24, 2013
Last Update Posted : May 24, 2013
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.
Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.
In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.
|Condition or disease||Intervention/treatment||Phase|
|High Risk HLA-A2+ Melanoma Metastatic Disease||Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2014|
|Experimental: Melanoma vaccine||Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand|
- Number of adverse effects [ Time Frame: For 20 weeks from the start of treatment ]
- Overall and disease free survival [ Time Frame: For at least five years ]
- Emergence of anti-tumor T cell reactivity [ Time Frame: To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start ]