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Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
This study has been completed.
Study NCT00020540   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
March 2001
 
 
 
Complete list of historical versions of study NCT00020540 on ClinicalTrials.gov Archive Site
 
 
 
Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
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.

Phase I
Interventional
Treatment
  • Kidney Cancer
  • Melanoma (Skin)
  • Biological: recombinant CD40-ligand
  • Biological: recombinant flt3 ligand
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer or melanoma Measurable disease

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT less than 2.5 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major active medical illness of the cardiovascular system (e.g., cardiac ischemia, myocardial infarction, or cardiac arrhythmia) Pulmonary: No major active medical illness of the respiratory system (e.g., obstructive or restrictive pulmonary disease) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No history of autoimmune disorders HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No prior systemic flt3 ligand or CD40-ligand Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent systemic steroids Radiotherapy: Prior localized radiotherapy for renal cell cancer or melanoma allowed Surgery: Prior surgery for renal cell cancer or melanoma allowed

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020540
 
CDR0000068601, NCI-01-C-0121, NCI-1035
National Cancer Institute (NCI)
 
Study Chair: Patrick Hwu, MD NCI - Surgery Branch
National Cancer Institute (NCI)
April 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP