Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
|ClinicalTrials.gov Identifier: NCT00020540|
Recruitment Status : Completed
First Posted : April 5, 2004
Last Update Posted : April 30, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin)||Biological: recombinant CD40-ligand Biological: recombinant flt3 ligand||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Official Title:||Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L|
|Study Start Date :||March 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020540
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Patrick Hwu, MD||NCI - Surgery Branch|