Study of the Modulatory Activity of an LHRH-Agonist (Leuprolide) on Melanoma Peptide Vaccines as Adjuvant Therapy in Melanoma Patients
This study uses vaccines named gp100 or MAGE-3 to immunize patients with melanoma. The type
of melanoma they will be used for contains a protein that is also found in the vaccines.
These vaccines are designed to stimulate immune cells, also called T cells, to recognize and
kill melanoma cells. Leuprolide will be studied to determine whether it will (is designed
to) improve your response to the vaccine.
If you are eligible for this treatment, you will be assigned to one of the two groups that
either receive one vaccine or two different vaccines, depending on your tissue type (either
gp100 vaccine alone or gp100 and MAGE-3 vaccines). A small amount of the vaccine(s) will be
injected under your skin to test your body's immune response to the vaccines. The size of
the skin reaction will be measured at 48-72 hours. This skin test will be done before you
receive any vaccine, at 6 months, and at 12 months, if possible.The participant and/or
participant's family will be given detailed verbal and written instructions on how to
measure any reaction to the skin tests. A data sheet and ruler (cm/mm) will be given to the
You will then be randomly assigned (as in the toss of a coin) to one of 2 treatment groups.
Participants in one group will receive leuprolide with the vaccine(s). Participants in the
other group will not receive leuprolide. Which group you are assigned to will depend
partially on your age.
If you are assigned to receive leuprolide injection, you will also have a bone mineral
density test to check on the strength of your bones.
Before the treatment starts, you will be asked to answer a questionnaire about your quality
of life and sexual functioning. Then at 3 months and 12 months of treatment, you will be
asked again to answer the same questionnaire. It should take about 20 minutes each time to
finish the questionnaire.
The vaccines will be injected in the skin every 3 weeks for a total of 48 weeks. Those
patients in Group I will receive 32 injections of peptide, whereas those patients in Group
II will receive 64 injections of peptide over a 48 week period. If you are assigned to
receive leuprolide, then leuprolide will be injected in the muscle at the beginning of the
study and at 12 weeks, for a total of 2 additional injections. Both the vaccine and
leuprolide injections will be given each time at the melanoma outpatient clinic at M. D.
Blood (about 4 teaspoons) will be taken at 6 weeks, 12 weeks, then every 12 weeks up to 48
weeks, or at any time if your tumor starts to grow back. Researchers will use this blood to
find out how well your immune cells are working to fight your tumor cells.
At around 24 weeks and 48 weeks into treatment, your will have CT scans of the chest,
abdomen and pelvis to check on the status of your disease. At around 24 weeks, if you are
receiving leuprolide and had an abnormal bone mineral density test before the treatment, you
will also have the second bone mineral density test to check on the strength of your bones.
You may be taken off study if your disease gets worse or intolerable side effects occur. If
you are taken off study, you will be asked to have repeat scans and a physical exam,
including blood (about 4 tablespoons) for routine tests.
Following the first 48 week treatment period, you will be evaluated every 3 months for one
year, every 4 months for one year, every 6 months for one year, and then once a year from
then on if clinically feasible.
You will have an MRI/CT of the brain, chest, abdomen and pelvis to check on the status of
your disease. If your disease gets worse or intolerable side effects occur, you will be
taken off study.
Blood (about 4 tablespoons) will be drawn for routine lab tests. An additional 4
tablespoons of blood will be drawn at each follow-up visit to determine how long the t-cell
counts remain high.
This is an investigational study. Gp100 and MAGE-3 vaccines are experimental and authorized
for research use only. Leuprolide is approved in treating prostate cancer patients and
other gynecological diseases, but is not approved for treatment of melanoma. Up to 100
patients will take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
T-cell responses to peptide vaccine
Reactivity to the gp100 peptide in each participant defined as >10 tetramer positive cells per 10^4 CD8+ T-cells as determined by the tetramer analysis at 3 months following initial vaccine. T-cell response will be measured approximately at baseline, 6, 12, and then every 12 weeks, up to 48 weeks following initial vaccine.
Up to 48 weeks following vaccine
Patrick Hwu, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|