Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the immunization effects of a vaccine for patients who are at risk
for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has
invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and
Drug Administration (FDA) has approved for preventing recurrence of melanoma is
alpha-interferon. But the research data are controversial. In this study, the vaccine to be
used, called gp100, contains a piece of a protein called a peptide, which melanoma cancer
cells produce.
Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue
type is tested as being human leukocyte antigen serotype within HLA-A serotype group
(HLA-A2), through a specific blood test, may be eligible for this study.
Up to 132 participants will be enrolled. There will be a physical examination and collection
of blood samples for tests, and making sure that x-rays and scans are current. Patients will
be randomly assigned to four groups. Group 1 will receive the peptide with an adjuvant
(assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2
will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for
treating genital warts and herpes but that may help immune cells in the skin to recognize the
vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed
in salt water given as several mini-doses under the skin of the thigh. Group 4 will also
receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to
the skin for 5 days. All patients will receive the gp100 every 3 weeks for 12 weeks. Every
dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not
return or patients do not experience side effects from this therapy, then the courses of
vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects
of the peptide vaccination include local swelling, swelling of local lymph nodes, bruising,
and pain and redness at the injection sites. There may be chills or fever. Patients will be
watched closely for such side effects.
To study how the vaccine changes the action of cells in the immune system, patients' white
blood cells (lymphocytes) will be obtained, involving a separate informed consent. The
procedure, called leukaphersis, requires inserting a needle into the arm, to obtain blood
going into a machine, which divides the blood into red cells, plasma (or the serum part), and
lymphocytes. The lymphocytes are removed, and the plasma and red cells returned to the
patient through a second needle in the other arm. Risks associated with the procedure include
fainting, which can be prevented by patients' eating before coming to the lab, and bleeding
and infection at the needle site. Patients will undergo leukapheresis will be done about four
times: before receiving the vaccine, 3 weeks after the first four doses, and then after 8
cycles and 12 cycles. Patients assigned to the groups receiving imiquimod will be asked to
record every time they apply that cream and describe any symptoms developed during the study.
All patients will be watched closely for any sign that their melanoma has returned. Before
and throughout the study, multiple blood tests will be conducted.
The vaccine, Montanide, and imiquimod may increase patients' immune system in fighting off
new tumors, but that is not known now. However, the study may provide information that will
be useful in treating melanoma patients in the future.