Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma

Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5
cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is
successfully made and if the patient is eligible, the patient will be assigned to receive
one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients
will receive injections of their vaccine as part of immune system testing and will receive
low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as
an injection into the skin of the arm over a 6 month period. Before and after vaccine
administration, patients will be tested for immunity to their own melanoma cells by DTH
testing, which is similar to a tuberculosis test. All side effects caused by the vaccine
will be recorded.

Inclusion Criteria:

- stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can
be excised to make vaccine good performance status

Exclusion Criteria:

- brain metastases need for steroids or other immunosuppressive drugs positive PPD
tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious
medical illnesses