Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 16 and over NCI NCI-01-C-0121 NCI-1035, NCT00020540, 1035

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.

Entry Criteria

Disease Characteristics:

Histologically confirmed metastatic renal cell cancer or melanoma

Measurable disease

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

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

Expected Enrollment

A total of 5 patients were accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Patrick Hwu, MD, Protocol chair(Contact information may not be current)		Ph: 866-820-4505 Email: patrick_hwu@nih.gov

Registry Information
Official Title		Treatment Of Patients With Metastatic Melanoma And Renal Cancer With A Combination Of Flt3L And CD40L
Trial Start Date		2001-03-06
Registered in ClinicalTrials.gov		NCT00020540
Date Submitted to PDQ		2001-03-13
Information Last Verified		2002-04-01