NCT01748747

Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery

Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the immune response of each immunization regimen and determine an optimal regimen in terms of immune response to recommend for phase II testing. SECONDARY OBJECTIVES: I. Evaluate the adverse events profile of each immunization regimen. II. Evaluate disease-free survival. TERTIARY OBJECTIVES: I. Describe the immunological efficacy of the vaccine preparations with Gag267-274 (Gag:267-274 peptide vaccine) and resiquimod, as measured by the frequency and interferon (IFN)gamma production of peptide-specific cytotoxic T lymphocytes (CTL). II. Examine immune responses to the tumor antigen analog MART-1a (MART-1 antigen) versus the xenoantigen Gag267-274. OUTLINE: Patients are assigned to 1 of 3 treatment groups. ARM I: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG subcutaneously (SC) on day 1. ARM II: Patients receive MART-1 antigen emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1. ARM III: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1. In all arms, treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Conditions

• Recurrent Melanoma
• Stage IIA Melanoma
• Stage IIB Melanoma
• Stage IIC Melanoma
• Stage IIIA Melanoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	Montanide ISA 51 VG	Given SC
BIOLOGICAL	MART-1 antigen	Given SC
OTHER	laboratory biomarker analysis	Correlative studies
BIOLOGICAL	Gag:267-274 peptide vaccine	Given SC
DRUG	resiquimod	Applied topically

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-12-14
• Completion: 2017-03-30
• First posted: 2012-12-12
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States