Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L
OBJECTIVES: I. Determine the maximum tolerated dose of CD40-ligand when combined with
fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer.
OUTLINE: This is a dose-escalation study of CD40-ligand. Patients receive fixed-dose flt3
ligand subcutaneously (SC) daily on days 1-14 and CD40-ligand SC daily on days 12-16.
Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable
toxicity or disease progression. Cohorts of 3 to 6 patients receive escalating doses of
CD40-ligand until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients
with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2
(IL-2) standard therapy.
PROJECTED ACCRUAL: A total of 5 patients were accrued for this study.
Primary Purpose: Treatment
Patrick Hwu, MD
NCI - Surgery Branch
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|