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

Sponsors and Collaborators:	Mayo Clinic National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00470379

Purpose

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	Intervention
Melanoma (Skin)	Drug: NY-ESO-1b peptide vaccine Drug: resiquimod Procedure: adjuvant therapy

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Resiquimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Transcutaneus (Topical) Peptide Immunization With NY-ESO-1b (SLLMWITQC) Peptide Using Resiquimod as an Immune Adjuvant: A Pilot Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Number and severity of hematologic and non-hematologic toxicities [ Designated as safety issue: Yes ]
Toxicity profile of each dose level [ Designated as safety issue: Yes ]
Percent of patients who mount an immune response [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470379

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Svetomir Markovic, MD, PhD	Mayo Clinic
Investigator:	Mark R. Pittelkow, MD	Mayo Clinic
Investigator:	James N. Ingle, MD	Mayo Clinic
Investigator:	Edward T. Creagan, MD	Mayo Clinic
Investigator:	Judith S. Kaur, MD	Mayo Clinic
Investigator:	Lori A. Erickson, MD	Mayo Clinic
Investigator:	Henry C. Pitot, MD	Mayo Clinic
Investigator:	Ravi D. Rao, MD, MBBS	Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000542630, MAYO-MC0578
Study First Received:	May 3, 2007
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00470379
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II melanoma
stage III melanoma
stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 14, 2009