Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery

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.

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin)
• Intervention / Treatment: Drug: resiquimod

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Prior diagnosis of melanoma meeting the following criteria:

  • Stage II-IV disease
  • Complete resection of disease
  • No current evidence of disease
• HLA-A2 positive
• No known standard therapy for disease that is potentially curative or proven capable of extending life expectancy exists

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 75,000/mm³
• AST ≤ 3 times upper limit of normal
• No uncontrolled or current infection
• No known allergy to vaccine or adjuvant components
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known immune deficiency

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy and recovered
• More than 4 weeks since prior biologic therapy
• No concurrent immunosuppressive therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunization with NY-ESO-1b; Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine.	Drug: resiquimod; Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and severity of hematologic and non-hematologic toxicities	4 weeks
Toxicity profile of each dose level	4 weeks
Percent of patients who mount an immune response	4 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 3, 2007
• First Submitted That Met QC Criteria: May 3, 2007
• First Posted (Estimate): May 7, 2007

Study Record Updates

• Last Update Posted (Estimate): October 31, 2014
• Last Update Submitted That Met QC Criteria: October 30, 2014
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: stage IV melanoma; stage III melanoma; stage II melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: MC0578 (Other Identifier: Mayo Clinic Cancer Center); P30CA015083 (U.S. NIH Grant/Contract); 169-06 (Other Identifier: Mayo Clinic IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No