Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery
- Registration Number
- NCT00470379
- Lead Sponsor
- Mayo Clinic
- Brief Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with resiquimod may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This clinical trial is studying the side effects, best dose, and best way to give vaccine therapy together with resiquimod in treating patients with stage II, stage III, or stage IV melanoma that has been completely removed by surgery.
- Detailed Description
OBJECTIVES:
* Determine the safety and immunization efficacy of the NY-ESO-1b peptide vaccine with resiquimod adjuvant in patients with completely resected stage II-IV melanoma.
* Collect, preliminarily, descriptive data on the impact of this regimen on time to melanoma relapse in these patients.
OUTLINE: This is a 3-step pilot, dose-escalation study of resiquimod.
* Step 1: Patients receive NY-ESO-1b peptide vaccine intradermally and topical resiquimod on day 1.
A cohort of 3-6 patients receives a maximal dose of resiquimod with NY-ESO-1b peptide vaccine.
* Step 2: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod on day 1.
Cohorts of 3-6 patients receive escalating doses of resiquimod until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
* Step 3: Patients receive topical NY-ESO-1b peptide vaccine and topical resiquimod at the step 2 dose as in step 2.
Cohorts of 3-6 patients receive resiquimod to increasing amounts of surface area until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT.
Blood is drawn at baseline and periodically during study treatment and observation. Samples are analyzed by flow cytometry, monoclonal antibody staining, ELISPOT, and ELISA.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Immunization with NY-ESO-1b resiquimod Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine.
- Primary Outcome Measures
Name Time Method Toxicity profile of each dose level 4 weeks Number and severity of hematologic and non-hematologic toxicities 4 weeks Percent of patients who mount an immune response 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States