Background:
- Recent cancer treatment studies have shown that altering a cancer patient's own white
blood cells may help the immune system fight the cancer. In all of these studies,
participants donate their own white blood cells through a procedure called
leukapheresis, and the cells are altered in the laboratory and given back to the
participants. After the cells are given, the patients receive aldesleukin (IL-2) to help
the tumor fighting cells stay alive longer. For individuals with metastatic melanoma,
pieces of melanoma proteins may be added to the collected white blood cells to help the
immune system recognize and attack the cancer cells.
- Researchers are interested in testing a new process in which cells from fruit flies
(Drosophila) are used to help the melanoma proteins attach to the white blood cells. The
fruit fly cells die off shortly after the proteins are introduced to the white blood
cells. Researchers are also interested in determining whether IL-2 treatment is
necessary after this new cancer treatment process.
Objectives:
- To test the safety and effectiveness of modified white blood cells (Drosophila-generated
CTL) as a treatment for metastatic melanoma that has not responded to standard
treatments.
- To determine whether IL-2 treatment improves the effectiveness of Drosophila-generated
cytolytic T lymphocytes (CTL).
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma that
has not responded to previous IL-2 treatment.
Design:
- Participants will be screened with a physical examination and medical history, tumor
imaging studies, and heart and lung function tests.
- Prior to treatment, participants will have an intravenous catheter inserted into the
chest to administer the study drugs.
- Participants will have leukapheresis to provide white blood cells for laboratory
modification.
- Seven days before the start of the treatment, participants will be admitted to the
hospital to have chemotherapy with cyclophosphamide and fludarabine. These drugs will
suppress the immune system to improve the effects of the treatment.
- One to four days after the last dose of chemotherapy, participants will receive the
modified cells. Participants in the group that will receive IL-2 will begin to receive
the treatment 24 hours after the cell infusion, every day for 5 days. All participants
will receive filgrastim injections to help the body produce more white blood cells.
- Participants will recover in the hospital for about 7 to 12 days after the cell infusion
or the last dose of IL-2. Participants will continue to receive medications and provide
blood and tumor samples for testing.
- Participants will have regular followup visits to assess the effects of the treatment.