Official Title: “NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant”

This study evaluates a cancer vaccine in melanoma patients who have resected melanoma but are at high risk for recurrence (stages IIB-III). This is a single arm, open label, pilot/phase I study evaluating safety and immunogenicity of NY-ESO-1 protein vaccination with Imiquimod as an adjuvant.

Imiquimod is a FDA approved immune response modifier for the treatment of HPV associated genital warts (but used for a different indication here) and has been shown to attract and mature dendritic cells in areas of topical application. This will be utilized in this application to inject a protein vaccine into this site, to prime and boost anti-NY-ESO-1 immune responses.

9 patients will be treated to receive 4 vaccination cycles, 21 days apart. Each vaccination cycle consists of topical application of Imiquimod 250mg to healthy skin of extremities for the first five days of each cycle and intradermal injection of NY-ESO-1 protein 100mcg to the pretreated area on day 3.

Immunization will be assessed by T-cell assays, NY-ESO-1 specific antibody titers, and evaluation of 3 small skin biopsies.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Biological: NY-ESO-1 protein
• Drug: Imiquimod

Primary Measures

• Safety

Secondary Measures

• Immunogenicity

Inclusion Criteria:

• Histologically confirmed, resected AJCC Stage IIB, IIC or III malignant melanoma
• Fully recovered from surgery
• Age >18 years.
• ECOG performance status <2
• Adequate organ and marrow function.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Chemotherapy, immunotherapy (including interferon), or radiotherapy within 4 weeks prior to first dosing of study agent.
• Prior treatment with NY-ESO-1 vaccines.
• Known HIV infection or autoimmune disease (RA, SLE). Patients with vitiligo or melanoma-associated hypopigmentation are not excluded.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to imiquimod or other agents used in the study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy or lactation.
• Women of childbearing potential not using a medically acceptable means of contraception.
• Patients with known history of inflammatory skin disorders, as imiquimod might exacerbate these conditions.
• Patients who receive chronic corticosteroid or immunosuppressive therapies.
• Lack of availability for immunological and clinical follow-up assessments.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ludwig Institute for Cancer Research

Overall Clinical Trial Officials and Contacts

Nina Bhardwaj, MD, PhD Principal Investigator New York University School of Medicine  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142454

Study ID Number: NYU 04-53, LUD2004-006

ClinicalTrials.gov Identifier: NCT00142454

Health Authority: United States: Food and Drug Administration