Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer
Status:
Terminated
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
Background:
- Some patients with advanced kidney cancer have immune cells that can recognize and kill
their cancer, but the cells are not active enough or numerous enough to accomplish this
on their own.
- In recent studies of patients with advanced melanoma, some patients given special
tumor-fighting cells (cells taken from the patient's tumor cells and grown in the
laboratory) showed some anti-tumor response.
Objectives:
-To determine whether special tumor-fighting cells taken from the patient's blood or tumor
and grown in the laboratory can cause tumors in patients with kidney cancer to shrink when
they are given back to the patient along with interleukin-2.
Eligibility: Patients 18 years of age or older with advanced kidney cancer.
Design:
- Up to 29 patients will be treated in this study.
- Patients undergo tumor biopsy to collect tumor cells for creating special tumor-fighting
cells for later infusion.
- Patients undergo apheresis 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.
- Before receiving the treated white cells, patients are given two drugs to suppress the
immune system so the treated cells can work without interference from immune system
cells. They are given cyclophosphamide over 2 days through a catheter (plastic tube
inserted into a vein in the arm or neck) and fludarabine through the catheter over 15-30
minutes for the next 5 days.
- The day after the last dose of fludarabine, the tumor-fighting cells are infused through
a vein over 10-20 minutes.
- Following the cell infusion, patients start treatment with high-dose interleukin-2 every
8 hours for a maximum of 12 doses.
- Patients are evaluated with x-ray studies about 1 month after receiving the cells and
interleukin 2 (IL-2) to look for tumor response to treatment. Those who show significant
improvement continue to receive treatment until the treated cells are used up or the
patient no longer benefits or develops unacceptable side effects.