Immunotherapy for Patients With Renal Cell Carcinoma
- Determine the response rate in patients with metastatic renal cell carcinoma treated
with HLA-partially matched related donor lymphocytes.
- Determine the rate and kinetics of clinical/radiological response in patients treated
with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the rates of graft-vs-host disease in patients treated with this regimen.
OUTLINE: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment
repeats every 8-16 weeks for up to 6 donor lymphocyte infusions in the absence of disease
progression or unacceptable toxicity.
Blood is collected periodically for research studies, including immunophenotypic analysis of
cells and assay for cytotoxic T-lymphocytes and natural killer-cell activity against target
After completion of study treatment, patients are followed for 60 days.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Roger Strair, MD, PhD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|