- This study will use cells called DMF5 to treat patients with metastatic melanoma
(melanoma that has spread beyond the primary tumor site).
- The DMF5 cells were first obtained from a tumor of a patient with melanoma with HLA-A201
tissue type. The tumor cells were grown in the laboratory, and when the laboratory-grown
cells were given back to the patient, the patient's tumors shrank dramatically. In
laboratory tests, DMF5 cells were also shown to shrink mouse melanoma tumors.
-To determine whether preparatory chemotherapy followed by infusion of DMF5 cells is a safe
and effective for shrinking melanoma tumors.
-Patients with metastatic melanoma and tissue type HLA-A201 who are 18 years of age or older.
- Patients have a preparatory regimen of chemotherapy with cyclophosphamide and
fludarabine followed by infusion of DMF5 cells and then high-dose interleukin. The
chemotherapy, interleukin and cells are given intravenously (through a vein).
- Patients have frequent blood tests to look for the side effects and response to
- Patients may be asked to have a tumor biopsy (surgical removal of a small piece of tumor
tissue) to examine the effects of treatment on the immune cells in the tumor.
- Patients have a physical examination, computed tomography (CT) of the chest, abdomen and
pelvis and laboratory tests 4 to 6 weeks after treatment and then monthly to evaluate
- The first group of patients participates in the Phase I portion of the study, called the
dose escalation phase. This phase will determine the highest safe dose of DMF5 cells.
There will be three dose levels of DMF5 cells, with the first patients enrolled getting
the smallest dose and then increasing the dose when the preceding level has been shown
to be safe.
- Patients in the Phase II portion of the study receive DMF5 cells at the highest dose
found to be safe in Phase I, to test the effectiveness of the treatment.