Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study|
- Number and severity of hematologic and non-hematologic toxicities [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Toxicity profile of each dose level [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Percent of patients who mount an immune response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Immunization with NY-ESO-1b
Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine.
Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470379
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|