A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma
- Compare the safety of vaccination comprising autologous dendritic cells loaded with
autologous tumor lysate and keyhole limpet hemocyanin with vs without non-myeloablative
fludarabine in patients with stage IV renal cell carcinoma.
- Compare, preliminarily, the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
- Determine whether this vaccine induces tumor-reactive peripheral T-cell responses or
delayed-type hypersensitivity in these patients.
OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment
All patients undergo surgery to remove tumor at metastatic sites to generate autologous
tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear
cells for the generation of dendritic cells (DC). The DC are then exposed to autologous
tumor lysate and keyhole limpet hemocyanin (KLH).
- Arm I: Three weeks after leukapheresis, patients receive vaccination comprising DC
loaded with autologous tumor lysate and KLH (DC vaccine) intradermally once every 14
days for a total of 4 injections in the absence of disease progression or unacceptable
- Arm II: Two weeks after leukapheresis, patients receive fludarabine IV over 15-30
minutes once daily for 3 days. Beginning approximately 5 weeks after leukapheresis,
patients also receive DC vaccine as in arm I.
Patients are followed at 1, 3, and 7-9 weeks, at 4, 6, 9, and 12 months, and then every 6
months for 2 years.
PROJECTED ACCRUAL: A total of 28 patients (14 per treatment arm) will be accrued for this
study within 2-3 years.
Allocation: Randomized, Primary Purpose: Treatment
Safety as measured by NCI common toxicity table at completion of study
John P. Hanson, MD
St. Luke's Medical Center
United States: Federal Government
|Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center||Milwaukee, Wisconsin 53201-2901|
|Midwest Heart Surgery Institute, Limited||Milwaukee, Wisconsin 53215|