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

NCT ID: NCT00470379

Last Updated: 2014-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-10-31

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immunization with NY-ESO-1b

Efficacy of maximal dose of topical resiquimod as immune adjuvant to intradermally administered NY-ESO-1b peptide vaccine.

Group Type: EXPERIMENTAL

resiquimod

Intervention Type: DRUG

Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.

Interventions

resiquimod

Escalating the dose of resiquimod applied to a fixed area of skin followed by application of topical NY-ESO-1b.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svetomir Markovic, MD, PhD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC0578

Identifier Type: OTHER

Identifier Source: secondary_id

169-06

Identifier Type: OTHER

Identifier Source: secondary_id

MC0578

Identifier Type: -

Identifier Source: org_study_id