Intraocular Melanoma, Melanoma (Skin)
Conditions
Keywords
recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, iris melanoma, recurrent intraocular melanoma, extraocular extension melanoma
Brief summary
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
Detailed description
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.
Interventions
BIOLOGICALMART-1 antigen
BIOLOGICALgp100:209-217(210M) peptide vaccine
BIOLOGICALtherapeutic autologous dendritic cells
BIOLOGICALtyrosinase peptide
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Progression-free survival | — |
| Time to progression | — |
| Toxicity | — |
Countries
United States
Outcome results
None listed