A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma
| Registry | NCT00031733 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; randomized, treatment |
| Enrollment | 60 (Actual) |
| Sponsor | University of Southern California (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Intraocular Melanoma, Melanoma (Skin) |
| Interventions | MART-1 antigen, gp100 antigen, incomplete Freund's adjuvant, recombinant interleukin-12, sargramostim, tyrosinase peptide, alum adjuvant, adjuvant therapy (Biological, drug, procedure) |
| Dates | start 2002-02-01, primary completion 2004-12-01, completion 2007-11-01, first posted 2003-01-27, last updated 2014-05-22 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Intraocular Melanoma All trials for Melanoma (Skin) All trials of MART-1 antigen All trials of gp100 antigen
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.
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.
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California | United States |