Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|