NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Imiquimod; NY-ESO-1 protein
Intervention description: Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream.; NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.
Intervention MeSH terms: Imiquimod
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Malignant melanoma; Stages IIB-III

Summary:

      This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with
      imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant
      melanoma. The primary study objective was to determine the safety of NY-ESO-1
      protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity
      of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had histologically confirmed, resected American Joint Committee on Cancer Stage IIB,
             IIC or III malignant melanoma

          -  Fully recovered from surgery

          -  Age ≥ 18 years; children were excluded from this study, as the safety of imiquimod had
             not been established in patients below the age of 18

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Adequate organ and marrow function as defined below:

               -  absolute neutrophil count: ≥ 1500/μL

               -  hemoglobin: ≥ 9 g/dL

               -  platelets: ≥ 100,000/μL

               -  total bilirubin: ≤ 1.5 × institutional upper limit of normal (ULN)

               -  aspartate aminotransferase/alanine aminotransferase (AST/ALT): ≤ 2.5 ×
                  institutional ULN

               -  creatinine: ≤ 1.5 × institutional ULN

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Received chemotherapy, immunotherapy (including interferon), or radiotherapy within 4
             weeks prior to first dosing of study agent

          -  Prior treatment with NY-ESO-1 vaccines

          -  Known human immunodeficiency virus infection or autoimmune disease (rheumatoid
             arthritis, systemic lupus erythematosus), as these conditions could have interfered
             with the evaluation of the induced immune response; patients with vitiligo or
             melanoma-associated hypopigmentation were 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 have limited
             compliance with study requirements

          -  Pregnancy or lactation

          -  Women of childbearing potential not using a medically acceptable means of
             contraception

          -  Known history of inflammatory skin disorders, as imiquimod might have exacerbated
             these conditions

          -  Chronic corticosteroid or immunosuppressive therapies, as these might have interfered
             with the evaluation of the induced immune response

          -  Lack of availability for immunological and clinical follow-up assessments