Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
Background:
- In a study in humans with melanoma, patients given total body irradiation to suppress
the immune system in conjunction with chemotherapy showed a significant clinical
response.
- In previous studies, about one-half of patients given tumor-fighting cells (cells
created from the patient's tumor cells and grown in the laboratory) showed some
anti-tumor response.
Objective: To determine whether tumor-fighting cells taken from a melanoma tumor and grown in
the lab can more effectively at fight melanoma when the patient's immune system is suppressed
and cannot attack them.
Eligibility: Patients 18 years of age or older with metastatic melanoma who have tumor
reactive cells available.
Design:
-Patients are assigned to one of two groups - those having received prior therapy with
Interleukin-2 (IL-2) and those who have not.
After five days of injections of filgrastim, a medicine to stimulated the growth of white
blood cells, patients undergo apheresis or bone marrow harvesting, or both, to collect stem
cells for later re-infusion. For apheresis, whole blood is collected through a needle in an
arm vein and circulated through a cell-separating machine where the stem cells are extracted.
The rest of the blood is returned through the same needle or a needle in the other arm. Bone
marrow harvesting is done under general anesthesia. Stem cells are collected through a large
needle inserted into the hipbone.-Patients' immune system cells and bone marrow function are
eliminated with chemotherapy (7 days) and total body irradiation (3 days) so the patient's
immune system cells will not fight the tumor-fighting cells they are given in treatment.
- 1 to 3 days after total body irradiation, patients receive the tumor-fighting cells by
intravenous (IV) infusion. After the cells are infused, they receive interleukin-2
(IL-2) infusions every 8 hours for 5 days.
- 2 days after infusion of the tumor-fighting cells, patients receive the stem cells
collected earlier by apheresis.
- Patients are evaluated 4 to 6 weeks after cell infusion to look for tumor response to
treatment. Patients whose tumor has not grown return to the National Institutes of
Health (NIH) every 1 to 3 months for blood tests, scans and x-rays.