Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This study will examine the effectiveness and side effects of an experimental vaccine to
prevent recurrence of melanoma. The likelihood of melanoma returning is higher in patients
who have melanoma lesions deep in the skin, in patients who have had positive lymph nodes,
and in patients who have had surgery for metastatic disease (cancer that has spread beyond
the primary site). Melanoma tumors produce proteins called glycoprotein 100 (gp100) and
melanoma-associated antigen recognized by T cells 1 (MART-1). Vaccination with specific
pieces of these proteins (peptides) may boost the immune system's fight against the cancer.
The vaccine injections are mixed with an oil-based substance called Montanide ISA-51, which
is intended to increase the immune response to the peptide.
Patients 16 years of age and older whose melanoma has been surgically removed and who are
currently free of disease may be eligible for this study. Candidates will be screened with a
physical examination and blood and urine tests. An electrocardiogram (EKG), x-rays and other
imaging studies will be done if recent results are not available. Some candidates may require
heart tests, such as a cardiac stress test or echocardiogram, or lung function tests. In
addition, all candidates will be tested for human leukocyte antigen (HLA) tissue type;
patients must be type human leukocyte antigens (HLA-A)*0201, the type on which this vaccine
is based.
Participants will be randomly assigned to receive one of four different vaccines to determine
which peptides offer the best immunity. Each treatment course consists of two injections of
the vaccines every 3 weeks for four times. The injections are given under the skin of the
thigh. After every other treatment course (every 6 months), patients will undergo a series of
x-rays and scans to look for tumor. The immunizations may continue for up to 12 months as
long as the melanoma does not return. The injections are given at the National Institutes of
Health (NIH) Clinical Center. Patients are monitored for 1 hour after each injection and have
blood tests and a physical examination to look for treatment side effects.
Patients will be followed with blood tests every 12 weeks to monitor body functions. They
will also undergo leukapheresis-a procedure to collect white blood cells-before starting
treatment and about 3 to 4 weeks after the fourth vaccine to evaluate how the vaccines affect
the action of the immune system cells. For this procedure, blood is drawn through a needle in
the arm, similar to donating blood. The blood goes through a machine that separates out the
lymphocytes (white blood cells), and the rest of the blood is returned through a needle in
the other arm. Some patients may undergo a biopsy-surgical removal of a small piece of tissue
under local anesthetic-of normal skin and tumor or lymph node tissue to examine the effects
of the vaccines on the tumor immune cells.
Patients whose disease returns during the first course of vaccine therapy will have surgery
to remove the tumor and will continue to receive the vaccine treatment. Patients whose tumor
returns after completing one course of therapy may receive a substance called interleukin-2
(IL-2), which can boost immune function against the tumor. interleukin-2 (IL-2) is given
intravenously (through a small tube placed in a vein) every 8 hours for 4 days. This regimen
is repeated after 10 to 14 days. Those who respond to interleukin-2 (IL-2) will have a third
course of treatment after 2 months. Patients whose disease recurs after treatment will be
taken off the study and will be referred back to their referring physician or to another
study, if an appropriate one is available.