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

NCT00470379 | Completed Early Phase 1 DMC

• 3 other identifiers: MC0578P30CA015083169-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage II melanoma; stage III melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Immunization with NY-ESO-1b

EXPERIMENTAL

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

Drug: resiquimod

Interventions

resiquimod DRUG

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

Immunization with NY-ESO-1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

resiquimod

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: April 1, 2006
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 31, 2014

Record last verified: 2012-06

Locations

US (1)