Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This experiment will test the safety and effectiveness of a treatment for melanoma in which
certain lymphocytes (a type of white blood cell) are taken from the patient, grown in the
laboratory, and returned after the patient's immune system has been weakened with
immune-suppressing drugs. Some patients will also receive interleukin-2 (IL-2), a drug that
may enhance the activity of the re-infused lymphocytes.
Patients with metastatic melanoma (melanoma whose tumor has spread) who have been treated
unsuccessfully with gp100 vaccination may participate in this study. They will undergo
apheresis or a tumor biopsy, or both, to collect lymphocytes. In apheresis, whole blood is
drawn through a needle in the arm. A machine separates the blood components and removes the
white cells. The rest of the blood is returned to the donor through a needle in the other
arm. A biopsy is a surgical procedure to remove a small piece of tumor tissue.
Several weeks before the lymphocytes are collected, patients will receive injections of
growth colony stimulating factor (G-CSF) every day for five days. This drug stimulates white
cell production, permitting as many cells as possible to be obtained during collection. The
lymphocytes will then be grown in larger numbers in the laboratory.
Seven days before the cells are re-infused, the patient is admitted to the hospital and a
catheter (small tube) is placed in a large vein in the chest or neck. Two drugs,
cyclophosphamide and fludarabine, are given through the tube. These drugs suppress the immune
system so that it will not interfere with the work of the reinfused lymphocytes. The
lymphocytes are then injected through the catheter over a 30-minute period. After the
infusion, patients who receive IL-2 will be given the drug in a high dose over a 15-minute
period every eight hours for up to five days. Patients whose condition does not permit
high-dose IL-2, such as those with a heart condition or lung problem, may receive a low-dose
regimen, with the drug given as a shot under the skin of the thigh or abdomen for five days
followed by a 2-day break, continuing for a total of six weeks. These patients receive a
higher dose the first week and then half that dose the next five weeks.
Blood and tissue samples will be taken before and during the study to evaluate the size of
the tumor and assess treatment. If, 3-5 weeks after therapy is completed, the patient's tumor
has stabilized or shrunk, the entire treatment, except for chemotherapy, may be repeated two
more times.