Melanoma (Skin) Clinical Trial
Official title:
Transcutaneous (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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