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

Alternate Title

flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	NCI-98-C-0040 NCI-T97-0092, T97-0092, NCT00019396

Objectives

I. Evaluate the immunologic and biologic activity of flt3 ligand (Flt3L) alone 
in patients with metastatic renal cell cancer or HLA-A2.1 negative melanoma.

II. Evaluate the immunologic and biologic activity of Flt3L alone or in 
combination with melanoma peptide immunization (MART-1, gp100:209-217, 
gp100:280-288, and tyrosinase) in patients with metastatic, HLA-A2.1 positive 
melanoma. 

Entry Criteria

Disease Characteristics:

Histologically proven metastatic melanoma or renal cell cancer
 Patients receiving melanoma peptide immunizations must be HLA-A2.1 positive

Measurable disease

Prior/Concurrent Therapy:

Biologic therapy:
 At least 1 month since prior biologic therapy

Chemotherapy:
 At least 1 month since prior chemotherapy

Endocrine therapy:
 No concurrent systemic steroid therapy
 At least 1 month since prior steroid therapy

Radiotherapy:
 At least 1 month since prior radiotherapy

Surgery:
 Prior surgery allowed

Other: 
 Greater than 1 month since prior therapy

Patient Characteristics:

Age:
 Not specified

Performance Status:
 ECOG 0-1

Life Expectancy:
 Greater 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 times normal
 
Renal:
 Creatinine no greater than 2 mg/dL

Cardiovascular:
 No major cardiovascular disease

Pulmonary:
 No major pulmonary disease

Other:
 Not pregnant or nursing
 Negative pregnancy test
 HIV negative
 Hepatitis B surface antigen negative
 No allergic reaction to Montanide ISA-51
 No active systemic infection
 No prior autoimmune disorders

Expected Enrollment

Approximately 54-96 patients (18-32 per treatment group) will be accrued for 
this study within 16 months.

Outline

Patients are assigned to 1 of 3 treatment groups:

Group 1 (renal cell cancer): Patients receive Flt3 ligand (Flt3L) 
subcutaneously (SQ) alone on days 1-14.  

Group 2 (HLA-A2.1 negative melanoma): Patients receive Flt3L SQ alone on days 
1-14.  

Group 3 (HLA-A2.1 positive melanoma): Patients may receive either Flt3L SQ 
alone on days 1-14 or in combination with melanoma peptide immunization.  
Patients may receive melanoma peptide immunization comprised of MART-1 
immunodominant peptide, gp100:209-217, gp100:280-288, and tyrosinase peptide 
emulsified in Montanide ISA-51 SQ on day 12 of Flt3L administration.  

Treatment repeats every 4 weeks for 2 courses.  Patients with no response or 
minor response may receive 2 additional courses.  Patients with disease 
progression after 1 course are removed from study.

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		A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
Registered in ClinicalTrials.gov		NCT00019396
Date Submitted to PDQ		1998-01-09
Information Last Verified		2002-09-01