Kidney Cancer Clinical Trial
Official title:
Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L
RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to
stimulate the immune system and stop cancer cells from growing. Biological therapy may be an
effective treatment for metastatic melanoma and metastatic kidney cancer.
PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in
treating patients who have metastatic melanoma or metastatic kidney cancer.
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
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