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Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer

This study has been completed.
Study NCT00020540.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
Official Title  Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L
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 Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Kidney Cancer
Melanoma (Skin)
Intervention  Drug: recombinant CD40-ligand
Drug: recombinant flt3 ligand
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  March 2001
Completion Date
Eligibility Criteria 

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

Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00020540
Organization ID CDR0000068601
Secondary IDs †† NCI-01-C-0121, NCI-1035
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Patrick Hwu, MD     NCI - Surgery Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2002
First Received Date  July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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