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

Alternate Title

Vaccine Therapy Followed by Biological Therapy 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-10M991 NCI-G00-1837, NCI-T99-0102, NCT00006113, T99-0102

Objectives

1. Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
2. Determine the toxicities of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic melanoma
  • Measurable disease after attempted curative surgery
  • Unresectable stage III or IV uveal melanoma
  • Metastatic mucosal melanoma
• HLA-A2.1 positive
• No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens

Chemotherapy:

• At least 1 month since prior chemotherapy for melanoma

Endocrine therapy:

• No concurrent steroid therapy

Radiotherapy:

• At least 1 month since prior radiotherapy for melanoma

Surgery:

• See Disease Characteristics

Other:

• At least 1 month since prior adjuvant therapy for melanoma
• At least 1 month since other prior therapy for melanoma

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 75,000/mm³
• Hemoglobin at least 9.0 g/dL
• No coagulation disorders

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No myocardial infarction within the past 6 months
• Patients with documented or suspected coronary artery disease must undergo stress thallium test
• No major cardiovascular illness

Pulmonary:

• No major pulmonary illness

Immunologic:

• HIV negative
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative
• No history of uveitis or autoimmune inflammatory eye disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No major systemic infection
• No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

Expected Enrollment

A total of 21-41 patients will be accrued for this study within 18-24 months.

Outline

This is a multicenter study.

Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, then every 3 months for 2 years, then 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 Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated with CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients with Metastatic Melanoma
Trial Start Date		1999-06-23
Registered in ClinicalTrials.gov		NCT00006113
Date Submitted to PDQ		2000-07-05
Information Last Verified		2003-10-03
NCI Grant/Contract Number		CA14089

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