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
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
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
OBJECTIVES:
- 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.
- Determine the toxicities of this regimen in these patients.
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.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24
months.
Inclusion 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)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 75,000/mm^3
- 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jeffrey S. Weber, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068125 (10M-99-1)
NCT ID:
NCT00006113
Start Date:
June 1999
Completion Date:
April 2006
Related Keywords:
- Melanoma (Skin)
- stage III melanoma
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
