Chemotherapy Followed by gp100 Lymphocytes and Aldesleukin to Treat Melanoma
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
Background:
This study uses a new experimental procedure for treating melanoma that uses the patient's
own lymphocytes (type of white blood cell), which are specially selected to target and
destroy their tumor.
Objectives:
To determine whether this experimental treatment can cause the patient's tumor to shrink.
To test the safety of the treatment and its effects on the immune system.
Eligibility:
Patients with metastatic melanoma 18 years of age and older for whom standard treatments are
not effective or who cannot take high-dose interleukin-2 (IL-2).
Patients must have the tissue type human leukocyte antigens (HLA-A)0201.
Design:
Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed.
Patients have leukapheresis (a procedure for collecting lymphocytes that is similar to
collecting whole blood) to collect cells for laboratory treatment and later reinfusion.
Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune system to
receive the cultured lymphocytes.
Cell infusion and IL-2 treatment: Patients receive the lymphocytes by infusion through a vein
and then either high-dose IL-2 infused through a vein or low-dose IL-2 injected under the
skin. High-dose IL-2 is given as infusions through a vein every 8 hours for up to 15 doses.
Low-dose IL-2 is given as injections under the skin daily for 5 days, followed by a 2-day
rest, with this regimen repeated for a total of 5 weeks.
Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and
IL-2.
Tumor biopsy: Patients may be asked to have a biopsy (removal of a small piece of tumor)
after receiving treatment to look at the effects of treatment in the tumor.
Follow-up: After treatment is completed, patients return to the clinic for physical
examinations, review of side effects, laboratory tests and scans every 1 to 6 months until
the disease worsens.
Retreatment: Patients whose tumor did not grow after treatment or showed evidence of
shrinking may be able to be retreated if their tumor begins to grow. They receive the same
regimen of chemotherapy, lymphocyte infusion and IL-2 treatment....