Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
- Determine progression-free survival of patients with metastatic clear cell renal cell
carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.
- Determine rates and kinetics of clinical/radiographic response in these patients.
- Determine toxicities associated with treatment in these patients.
- Assess stable disease at 6 months in these patients.
- Assess overall survival of these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 4 weeks. Treatment repeats
every 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning with
course 2 of sunitinib malate, patients also receive irradiated allogeneic lymphocytes IV
over 1 hour every 8-16 weeks for up to 6 infusions in the absence of disease progression or
After completion of study treatment, patients are followed periodically for 60 days.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment start date to date of progression
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|