A Novel Treatment for Metastatic Melanoma

A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating
cream with or without injection of a substance that makes the tumor more sensitive to the
laser.

Inclusion Criteria:

1. Age 18 and older

2. Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous
metastatic malignant melanoma from any tumor site.

3. Subjects must have measurable disease. See section 10.2 for the evaluation of
measurable disease (RECIST).

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

5. Required laboratory parameters (all blood tests must be obtained within 14 days
prior to the start of the study treatment):

Platelet count > 40,000 per mm3 Absolute Neutrophil Count (ANC) > 1,500 per mm3

Exclusion Criteria:

1. Life expectancy, in the opinion of the investigator of less than 4 months

2. Known allergy to any drugs used in treatment

3. Immunosuppression, including HIV positive subjects, use of systemic steroids daily or
other immunosuppressive medications within 1 month of treatment

4. Chemotherapy/immunotherapy within 4 weeks of initiation

5. Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation

6. Radiation therapy at the treatment site within 4 weeks of initiation

7. Uncontrolled brain metastases

8. History of cutaneous photosensitization or photodermatoses

9. Non-treated, active cancers other than melanoma and non-melanoma skin cancers.

10. Active infectious disease requiring antibiotic therapy

11. Unstable medical illness

12. Past or present major psychiatric illness

13. Pregnant or lactating women

14. End stage renal disease or serum creatinine greater than the upper limit of normal or
creatinine clearance <50cc/min

15. Acute hepatitis (any cause)