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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142454
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 21, 2007
American Society of Clinical Oncology
Information provided by:
Ludwig Institute for Cancer Research

September 1, 2005
September 2, 2005
September 21, 2007
August 2005
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Same as current
Complete list of historical versions of study NCT00142454 on Archive Site
Same as current
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NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant

This study evaluates a cancer vaccine in melanoma patients who have resected melanoma but are at high risk for recurrence (stages IIB-III). This is a single arm, open label, pilot/phase I study evaluating safety and immunogenicity of NY-ESO-1 protein vaccination with Imiquimod as an adjuvant.

Imiquimod is a FDA approved immune response modifier for the treatment of HPV associated genital warts (but used for a different indication here) and has been shown to attract and mature dendritic cells in areas of topical application. This will be utilized in this application to inject a protein vaccine into this site, to prime and boost anti-NY-ESO-1 immune responses.

9 patients will be treated to receive 4 vaccination cycles, 21 days apart. Each vaccination cycle consists of topical application of Imiquimod 250mg to healthy skin of extremities for the first five days of each cycle and intradermal injection of NY-ESO-1 protein 100mcg to the pretreated area on day 3.

Immunization will be assessed by T-cell assays, NY-ESO-1 specific antibody titers, and evaluation of 3 small skin biopsies.

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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Melanoma
  • Biological: NY-ESO-1 protein
  • Drug: Imiquimod
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2007
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Inclusion Criteria:

  • 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 document.

Exclusion Criteria:

  • 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 study requirements.
  • Pregnancy or lactation.
  • Women of childbearing potential not using a medically acceptable means of contraception.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NYU 04-53, LUD2004-006
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Ludwig Institute for Cancer Research
American Society of Clinical Oncology
Principal Investigator: Nina Bhardwaj, MD, PhD New York University School of Medicine
Study Director: Sylvia Adams, MD New York University School of Medicine
Ludwig Institute for Cancer Research
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP