IL15 Dendritic Cell Vaccine for Patients With Resected Stage III (A, B or C) or Stage IV Melanoma

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.

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