Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells
Status:
Terminated
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Background:
- Some cancer treatments collect a patient s own blood cells to use as specialized
cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood
lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with
PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can
survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new
cells grow. Researchers want to see if special white blood cells that recognize a specific
protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can
cause tumors to shrink. These white blood cells will be tested with and without aldesleukin.
Objectives:
- To test the safety and effectiveness of white blood cells that target MART in the
treatment of melanoma.
- To test white blood cells that target MART with and without aldesleukin.
Eligibility:
- Individuals at least 18 years of age who have melanoma that has not responded to standard
treatments.
Design:
- Participants will be screened with a medical history and physical exam. Blood and urine
samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging
scans will be performed.
- Participants will provide white blood cells through leukapheresis. Researchers will
attempt to isolate white blood cells that recognize MART
- Seven days before the start of treatment, participants will have chemotherapy.
- After the last dose of chemotherapy, participants will receive the MART reactive PBL
cells. Filgrastim doses will also be given to help white blood cell counts return to
normal. Participants will have frequent blood tests.
- Participants who are able to have aldesleukin treatment will start within 24 hours after
receiving the MART reactive PBL cells. Treatment will continue for up to 5 days.
- Participants may have an optional tumor or lymph node biopsy to study the effects of
treatment.
- If the tumor continues to grow after MART PBL treatment, participants may have one more
round of cell collection and treatment.
- Participants will have followup visits for up to 6 months after receiving the MART
reactive PBL treatment.