Status:
COMPLETED
NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Cancer Research Institute, New York City
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Patients applied imiquimod (250 mg) topically to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 conse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2006
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00142454
Start Date
August 24 2005
End Date
April 25 2006
Last Update
October 10 2022
Active Locations (1)
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1
NYU Cancer Institute
New York, New York, United States, 10016