NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)

• Status: Completed
• Trial end date: 2006-04-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Collaborators: American Society of Clinical Oncology; Cancer Research Institute (CRI)
• Treatments: Imiquimod

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