Expired Study
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Dallas, Texas 75246


Purpose:

The purpose of the study is to gather data on feasibility as well as immune and clinical efficacy of of a dendritic cell vaccine using IL15 in patients with resected stage III or stage IV melanoma


Study summary:

IL15 is a T cell growth factor that pre-clinical data overwhelmingly suggests could have a very important role in cancer immunotherapy. A desirable property for a dendritic cell vaccine directed against cancer is the ability to efficiently prime naïve, tumor associated antigen specific T cells into potent CTLs. Results of studies in healthy volunteers have shown that IL15 DCs are particularly efficient at priming functional melanoma specific CD8+ T cells. The use of IL15 in the manufacture of the DC vaccine could result in an improved immunotherapy product.


Criteria:

Inclusion Criteria: - HLA A201 + phenotype - Biopsy-proven melanoma, Stages III (A, B and C) or stage IV.- no evidence of disease at study entry - Age: 21-75 years - ECOG performance status 0-1 - Adequate marrow function - Adequate hepatic function - Adequate renal function - Written informed consent Exclusion Criteria: - Subjects with measureable non-resectable melanoma - Subjects who have had chemotherapy less than 4 weeks before starting trial - Subjects who received IFN-a or GM-CSF less than 4 weeks before starting trial - Subjects who received IL2 less than 4 weeks before starting trial - Subjects with a baseline LDH greater than 1.1 times the ULN - Subjects who are HIV positive - Female subjects who are pregnant - Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial - Subjects who have asthma and/or are on treatment for asthma - Subjects with angina pectoris - Subjects with congestive heart failure - Subjects with history of autoimmune disease including lupus, rheumatoid arthritis or thyroiditis - Subjects with active infections including viral hepatitis - Subjects with a history of neoplastic disease othe than melanoma within the last 5 years - History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin. - Subjects who present with open wounds


NCT ID:

NCT01189383


Primary Contact:

Principal Investigator
Joseph Fay, MD
Baylor Health Care System


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75246
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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