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

Alternate Title

Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI LAC-USC-10M011 LAC-USC-IRB-013030, NCI-5506, NCT00031733, 5506

Objectives

1. Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).

Entry Criteria

Disease Characteristics:

• Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma
  • Resected or rendered disease-free



• HLA-A2.1-positive by standard cytotoxicity assay



• Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry
  • Must be positive for at least 1 antigen



• Failed, ineligible for, or refused prior interferon alfa

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides

Chemotherapy:

• At least 1 month since prior adjuvant chemotherapy for this disease
• No concurrent adjuvant chemotherapy

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• At least 1 month since prior radiotherapy for this disease
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 1 month since other prior therapy, including adjuvant therapy, for this disease
• No other concurrent therapy, including adjuvant therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9.0 g/dL
• No bleeding disorder

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• SGOT/SGPT no greater than 2.5 times normal
• No coagulation disorder
• Hepatitis surface antigen B negative
• Hepatitis C negative

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No major cardiovascular illness

Pulmonary:

• No major respiratory illness

Immunologic:

• No prior uveitis
• No prior autoimmune inflammatory eye disease
• No immune hemolytic anemia
• No other active autoimmune disease

Other:

• HIV negative
• No major gastrointestinal illness
• No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago
• No major systemic infection (e.g., pneumonia or sepsis)
• No other major medical illness
• No prior allergic reaction to Montanide ISA-51 or alum adjuvant
• No requirement for steroid therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.

Outline

This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.



• Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.



• Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

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 Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified with Montanide ISA 51 with Interleukin-12 with Alum or GM-CSF for Patients with Resected Stages IIB/C, III and IV Melanoma
Trial Start Date		2002-02-27
Registered in ClinicalTrials.gov		NCT00031733
Date Submitted to PDQ		2002-01-09
Information Last Verified		2005-02-24
NCI Grant/Contract Number		CA14089, CA90751