Intraocular Melanoma, Melanoma (Skin)
Conditions
Keywords
iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
Brief summary
RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Detailed description
OBJECTIVES: * 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). 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. PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.
Interventions
BIOLOGICALMART-1 antigen
BIOLOGICALgp100 antigen
BIOLOGICALincomplete Freund's adjuvant
BIOLOGICALrecombinant interleukin-12
BIOLOGICALsargramostim
BIOLOGICALtyrosinase peptide
DRUGalum adjuvant
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * 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 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
Countries
United States
Outcome results
None listed