Trial Information

Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™

OBJECTIVES:

- Determine the response in patients with in-transit cutaneous malignant melanoma treated
with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).

OUTLINE: This is an open-label, multicenter study.

Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and
groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up
to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of
response at week 24 receive no further treatment. Patients whose disease continues to
respond after completion of study treatment are eligible for a new study in which they will
continue treatment with polyvalent melanoma vaccine (Canvaxin™).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.