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

Alternate Title

Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 16 and over NCI NCI-98-C-0023 NCI-T97-0089, T97-0089

Objectives

I. Identify whether patients with refractory metastatic melanoma undergo 
clinical response to immunization comprising immunodominant peptides from 3 
melanoma antigens (MART-1, gp100, and tyrosinase) alone (arm closed) or when 
combined with 1 of 3 adjuvants.

II. Identify the immunologic response to peptide immunization alone (arm 
closed) or when combined with 1 of 3 adjuvants, as measured principally by 
changes in T-cell precursors from before treatment until after treatment.

III. Evaluate the immunologic parameter changes in a variety of possible 
assays in patients treated with this regimen.

IV. Evaluate the toxicity profiles of peptide immunization alone (arm closed) 
or when combined with 1 of 3 adjuvants in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed refractory metastatic melanoma

Measurable disease

Must be HLA-A0201

Prior/Concurrent Therapy:

Biologic therapy:
 At least 3 weeks since prior biologic therapy
 No concurrent biologic therapy

Chemotherapy:
 At least 3 weeks since prior chemotherapy
 No concurrent chemotherapy

Endocrine therapy:
 At least 3 weeks since prior endocrine therapy
 No concurrent steroids or other endocrine therapy

Radiotherapy:
 At least 3 weeks since prior radiotherapy
 No concurrent radiotherapy

Surgery:
 Prior surgery allowed

Patient Characteristics:

Age:
 16 and over

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 or ALT less than 2 times normal
 
Renal:
 Creatinine no greater than 2.0 mg/dL

Cardiovascular:
 No major cardiovascular illness

Pulmonary:
 No major pulmonary illness

Other: 
 HIV negative  
 Hepatitis B surface antigen negative
 No active systemic infection
 No known immunodeficiency disease
 No known allergic reaction to Montanide ISA-51
 Not pregnant
 Fertile patients must use effective contraception

Expected Enrollment

A maximum of 114 patients will be accrued for this study within 1.5 years.

Outline

Patients receive peptide immunization comprising MART-1:27-35, 
gp100:209-217, gp100:280-288, and tyrosinase:368-376.  Patients receive 4 
different peptides separately emulsified in Montanide ISA-51 via 4 separate 
subcutaneous injections into 4 different sites.  Treatment repeats every 3 
weeks for 4 courses. (Arm closed) 

Patients are treated with peptide immunization alone or combined with 1 of 3 
adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV (cohort closed), or 
sargramostim (GM-CSF) subcutaneously) depending on the time of entry into 
study and response to treatment. 

At least 4 to 6 patients are accrued for the peptide alone cohort before 
beginning accrual for the other cohorts.  Any patient who develops 
unacceptable toxicity due to vaccine injections is taken off study.  If a 
second patient develops unacceptable toxicity, then that schedule of peptide 
administration is discontinued.  Any patient who develops unacceptable 
toxicity due to cytokine treatment which is not reversed within 96 hours is 
taken off study.  Patients with stable or responding disease may receive a 
maximum of 12 additional courses.  Patients with complete response may receive 
a maximum of 2 additional courses.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

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