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

Completed · Phase 1

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT00142454

Run by

Ludwig Institute for Cancer Research

People needed

9

Starts

2005-08-24

Expected to finish

2006-04-25

Last updated by the study team

2022-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Cancer Institute — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.