Vaccine Treatment in Combination With IL-2 and Treated Lymphocytes for Advanced Melanoma
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This study will examine the effectiveness of treating advanced melanoma with special
tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory. The
cells are given along with infusions of a growth factor-like substance called interleukin-2
(IL-2) and an experimental vaccine called fowlpox gp100. This vaccine consists of a peptide
(part of a protein) called gp100 that is often found in melanoma tumors and chicken virus
(fowlpox) that has been altered so that it cannot produce illness in humans.
Patients 16 years of age and older with melanoma that has spread beyond the original site and
that does not respond to standard treatment may be eligible for this study. Candidates are
screened with a medical history and physical examination, chest x-ray, electrocardiogram,
blood and urine tests, and x-rays and scans to the evaluate the extent and size of the tumor.
Because the experimental preparation is based on tissue type, only patients with tissue type
HLA-A*0201 may participate. Tissue type is determined by a blood test.
Participants undergo the following procedures:
- Leukapheresis, a procedure for collecting lymphocytes (white blood cells): Using this
procedure, special cells with good tumor-fighting ability are selected and removed for
later re-infusion into the patient. To collect the cells, blood is withdrawn through a
needle in an arm vein and directed through a catheter into a cell-separating machine.
The lymphocytes are removed and the rest of the blood is returned to the body through
the same needle. Alternatively, lymphocytes may also be collected from biopsied tumor
tissue, obtained either with a needle or by a small cut in the tumor.
- G-CSF injections: This growth factor is injected under the skin every day for 5 days to
stimulate white blood cell production.
- Catheter placement: Upon admission to the Clinical Center for treatment, the patient has
a catheter (plastic tube) placed in a vein in the neck or arm for giving chemotherapy
and other medicines, for infusing the lymphocytes, and for collecting blood samples.
- Leukapheresis: Repeated in the hospital to collect and store blood that may be needed in
the rare event that the patient's blood components do not recover after chemotherapy.
- Chemotherapy: A week before the lymphocyte infusion, patients receive a 1-hour infusion
of cyclophosphamide for 2 days and then a 15- to 30-minute infusion of fludarabine for 5
days to suppress the immune system and thereby prevent rejection of the infused
lymphocytes.
- Vaccine and lymphocyte delivery: The vaccine is injected through the catheter, followed
by a 30-minute infusion of the lymphocytes.
- IL-2 and G-CSF: Patients receive IL-2 infusions every 8 hours for up to 5 days after the
cell infusion to help keep the cells alive, and G-CSF injections under the skin every
day after the cell infusion until white cells increase to a sufficient number. The
entire hospital stay is usually 12 to 16 days.
About 4 weeks after the lymphocyte infusion, patients are re-admitted to the hospital for
about 10 days for a second vaccine injection and course of IL-2 infusions. Between 2 and 4
weeks after completing the full treatment regimen, patients return to NIH for evaluation.
Those whose tumors have shrunk or remained stable may repeat the entire treatment regimen two
times. Those whose tumors continued to grow may be re-treated with infusion of lymphocytes
through an artery instead of a vein if their tumors receive blood from a major artery. If
this is not feasible, or if it is tried without success, the patients will be taken off the
study.