NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant
- 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.