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

Alternate Title

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Refractory Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	NCI-95-C-0079D NCI-T94-0195N, T94-0195

Objectives

I.  Evaluate the toxicity, immunologic reactivity, and possible therapeutic 
efficacy of immunization with recombinant adenovirus expressing the MART-1 
melanoma antigen administered alone or with interleukin-2 in patients with 
refractory metastatic malignant melanoma.

Entry Criteria

Disease Characteristics:

Metastatic melanoma that has failed standard therapy
  Histologic confirmation at NIH required

Measurable or evaluable disease required

Standard HLA typing of peripheral blood lymphocytes required

Prior/Concurrent Therapy:

Greater than 4 weeks since any prior therapy
No concurrent steroids

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  Greater than 3 months

Immunologic:
  HLA-A2.1-positive on standard HLA typing
  HIV seronegative
  HB Ag seronegative
  No active systemic infection
  No other major immunologic illness

Hematopoietic:
  WBC greater than 3,000/mm3
  Platelet count greater than 100,000/mm3
  Hb greater than 8.0 g/dL

Hepatic:
  Bilirubin no greater than 2.0 mg/dL
  SGOT/SGPT less than 4 x ULN

Renal:
  Creatinine no greater than 1.6 mg/dL

Cardiovascular:
  No major cardiovascular illness
  Negative stress thallium exam required in patients over age 50

Pulmonary:
  No major respiratory illness

Other:
  No coagulation disorder
  Negative pregnancy test required of fertile women
  Effective contraception required of fertile patients

Expected Enrollment

Up to 15 patients per dose level will be entered.

Outline

Vaccination with and without Biological Response Modifier Therapy.  
Recombinant adenovirus encoding the MART-1 melanoma antigen, MART-1; with and 
without Interleukin-2 (Chiron), IL-2, NSC-373364.

Rosenberg SA, Zhai Y, Yang JC, et al.: Immunizing patients with metastatic melanoma using recombinant adenoviruses encoding MART-1 or gp100 melanoma antigens. J Natl Cancer Inst 90 (24): 1894-900, 1998.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Rosenberg, MD, PhD, Protocol chair		Ph: 866-820-4505 Email: sar@nih.gov