Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L
Overview
- Phase
- Phase 1
- Status
- Completed
- Locations
- 1
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided