New York City,
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
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.
- 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
- 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
- Pregnancy or lactation.
- Women of childbearing potential not using a medically acceptable means of
- 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.