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

This study has been completed.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00142454
First received: September 1, 2005
Last updated: September 20, 2007
Last verified: September 2007

September 1, 2005
September 20, 2007
August 2005
Not Provided
Safety
Same as current
Complete list of historical versions of study NCT00142454 on ClinicalTrials.gov Archive Site
Immunogenicity
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Biological: NY-ESO-1 protein
  • Drug: Imiquimod
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
June 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00142454
NYU 04-53, LUD2004-006
Not Provided
Not Provided
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