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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00470379

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Drug: resiquimod	Early Phase 1

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

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic
National Cancer Institute (NCI)

Investigators

Study Chair: Svetomir Markovic, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00470379

Other Study ID Numbers:

MC0578
P30CA015083
MC0578
169-06

First Posted:

May 7, 2007

Last Update Posted:

Oct 31, 2014

Last Verified:

Jun 1, 2012

Keywords provided by Mayo Clinic

stage II melanoma

stage III melanoma

stage IV melanoma

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Oct 31, 2014