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

Alternate Title

Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI LAC-USC-10M973 NCI-G98-1432, NCI-T97-0099, NCT00003339, T97-0099

Objectives

I.  Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified 
with Montanide ISA-51 (ISA-51) with or without interleukin-12 following 
surgical resection in HLA-A2 positive patients with stage III or IV melanoma.

Entry Criteria

Disease Characteristics:

Histologically proven stage III or IV cutaneous or ocular melanoma that can be
completely resected or rendered free of disease but is at high risk of
recurrence
OR
Recurrent disease following interferon alfa or ineligible for or refused
interferon alfa

HLA-A2 positive

Tumor tissue must be available for analysis of gp100/tyrosinase expression
 Detectable expression of one or the other antigen not required

Prior/Concurrent Therapy:

Biologic therapy:
 See Disease Characteristics
 At least 1 month since prior biologic therapy

Chemotherapy:
 At least 1 month since prior chemotherapy, including adjuvant therapy

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

Radiotherapy:
 At least 1 month since prior radiotherapy

Surgery:
 See Disease Characteristics
 At least 1 month since prior surgery

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-1

Life expectancy:
 Not specified 

Hematopoietic:
 WBC at least 3,000/mm3
 Platelet count at least 100,000/mm3
 Absolute granulocyte count at least 1,500/mm3
 Hemoglobin at least 9 g/dL

Hepatic:
 Bilirubin no greater than 2 mg/dL
 
Renal:
 Creatinine no greater than 2.0 mg/dL
 Creatinine clearance at least 60 mL/min

Cardiovascular:
 No major cardiovascular illness

Pulmonary:
 No major respiratory illness (e.g., pneumonia)

Gastrointestinal:
 No major gastrointestinal illness

Other:
 Not pregnant or nursing
 No major systemic infection (e.g., sepsis)
 No coagulation or bleeding disorder
 HIV negative
 Hepatitis B surface antigen negative
 Hepatitis C surface antigen negative
 No history of uveitis or autoimmune inflammatory eye disease
 No active autoimmune disease
 Not allergic to Montanide ISA-51
 No active second malignancy within the past 5 years

Expected Enrollment

A total of 45 patients will be accrued for this study over 2 years.

Outline

This is a randomized, parallel study.  Patients are stratified by prior 
therapy (immunotherapy or chemotherapy vs surgery only).

Patients are randomized to receive 1 of 2 treatment arms:

Arm I:  Following surgery, patients receive tyrosinase and gp100 peptides 
emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly 
during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations.

Arm II: Following surgery, patients receive treatment as in Arm I followed by  
 interleukin-12 SQ once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for 
a total of 8 vaccinations.    

Patients are followed at 2-4 weeks, then every 3 months for 2 years after 
resection, then every 6 months for 3 years, and then yearly if without 
evidence of disease.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Jeffrey Weber, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 323-865-3962; 800-865-0102 Email: jweber@usc.edu

Registry Information
Official Title		A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified with Montanide ISA 51 With and Without Interleukin-12 for Patients with Resected Stages III and IV Melanoma
Trial Start Date		1998-11-01
Registered in ClinicalTrials.gov		NCT00003339
Date Submitted to PDQ		1998-05-22
Information Last Verified		2007-05-21