Adjuvant Therapy for Patients With Primary Uveal Melanoma With Genetic Imbalance

Inclusion Criteria

Inclusion

- Patients must have a diagnosis, either cytologic or histologic, of melanoma of the
iris, ciliary body and/or choroid

- Patient's tumor must exhibit monosomy 3 and/or 8q amplification as determined by
karyotype, CGH, PCR-based microsatellite, and/or FISH analysis; tissue or cells for
analysis can be obtained at enucleation, resection, or by FNA

- Patients must have undergone adequate primary therapy; this can include enucleation,
brachytherapy, proton beam radiotherapy, stereotactic irradiation, trans-scleral
local resection, transretinal resection or diode laser thermotherapy

- Patients must have had chest X-ray and hepatic ultrasound or other imaging methods
such as CT or MRI to eliminate distant disease

- Patients must have a performance status (ECOG) of < 2

- Patients must be entered within 56 days of completing primary therapy

- WBC >= 3.0 x 10^9/L

- Neutrophils >= 1.5 x 10^9/L

- Platelets >= 100 x 10^9/L

- INR and PTT < 1.5 x upper limit of normal

- Hemoglobin >= 10 gm/100 ml

- Creatinine =< 2 mg/dl

- Bilirubin (total) =< 1.5 mg/dl

- ALT =< 1.5 x upper limit of normal

- Alkaline phosphatase =< 1.5 x upper limit of normal

- AST =< 1.5 x upper limit of normal

- Patients must not have received any other systemic therapy for melanoma

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control) prior to study entry and for the
duration of study participation; should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician
immediately

- All patients must be informed of the investigational nature of this study and must
provide written informed consent in accordance with institutional and federal
guidelines; a copy of the informed consent document signed by the patient must be
given to the patient

Exclusion

- Patients with metastasis

- Patients that are pregnant or breastfeeding

- Patients may not be receiving any other investigational agents

- Patients with a history of immunodeficiency or autoimmune diseases are not eligible;
patients requiring therapy with corticosteroids or other immunosuppressives are not
eligible; patients requiring ongoing replacement therapy with physiologic doses of
corticosteroids will be eligible.

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements are not eligible

- Patients who are known to be positive for HIV or HepBAg

- No patient may have had a malignancy other than a malignant melanoma, with the
following exceptions: basal or squamous cell carcinomas of the skin; carcinoma
in-situ of the uterine cervix; any malignancy treated with curative intent and in
complete remission for > 3 years

- Patients with organ allografts