A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
16 Years
N/A
Both
Intraocular Melanoma, Melanoma (Skin)
Trial Information
A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
OBJECTIVES:
Primary
- Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma
treated with an intradermally administered vaccine comprising autologous dendritic
cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine
cocktail.
Secondary
- Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo
with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and
tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin
(IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22,
and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease
progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of melanoma
- Metastatic disease
- The following melanoma subtypes are eligible:
- Unresectable, stage III-IV uveal melanoma
- Metastatic mucosal melanoma
- Measurable disease after attempted curative surgical therapy
- Tumor tissue must be available for immunohistochemical staining
- Positive for ≥ 1 of the following peptides:
- MART-1: 26-35 (27L)
- gp100: 209-217 (210M)
- Tyrosinase: 368-376 (370D)
- HLA-A *0201 positive by DNA polymerase chain reaction assay
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 75,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- No major systemic infections
- No coagulation disorders
- No major medical illness of the cardiovascular or respiratory system
- No myocardial infarction within the past 6 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known HIV positivity
- No know positivity for hepatitis B surface antigen or hepatitis C antibody
- No prior uveitis or autoimmune inflammatory eye disease
- No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer
unless patient was curatively treated > 5 years ago and has no detectable disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 1 prior cytotoxic chemotherapy agent or regimen
- Prior biologic or antiangiogenic therapies allowed
- More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant
therapy, or any other therapy for melanoma
- No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D)
peptides
- No concurrent steroid therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
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:
10M-03-1
NCT ID:
NCT00334776
Start Date:
October 2003
Completion Date:
June 2005
Related Keywords:
- Intraocular Melanoma
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- ciliary body and choroid melanoma, medium/large size
- iris melanoma
- recurrent intraocular melanoma
- extraocular extension melanoma
- Melanoma
- Uveal Neoplasms
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
