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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470379
• Other study ID #: MC0578
• Secondary ID: P30CA015083MC057
• Status: Completed
• Phase: Phase 0
• First received: May 3, 2007
• Last updated: October 30, 2014
• Start date: April 2006
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of hematologic and non-hematologic toxicities		4 weeks	Yes
Primary	Toxicity profile of each dose level		4 weeks	Yes
Primary	Percent of patients who mount an immune response		4 weeks	No