Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baylor Research Institute
With
National Institutes of Health (NIH)
National Cancer Institute (NCI)
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.
Age
21–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
