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
  Purpose

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.


Condition Intervention Phase
Malignant Melanoma
Biological: NY-ESO-1 protein
Drug: Imiquimod
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant

Resource links provided by NLM:


Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Immunogenicity

Estimated Enrollment: 9
Study Start Date: August 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142454

Locations
United States, New York
NYU Cancer Institute
New York City, New York, United States, 10016
Sponsors and Collaborators
Ludwig Institute for Cancer Research
American Society of Clinical Oncology
Investigators
Principal Investigator: Nina Bhardwaj, MD, PhD New York University School of Medicine
Study Director: Sylvia Adams, MD New York University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00142454     History of Changes
Other Study ID Numbers: NYU 04-53, LUD2004-006
Study First Received: September 1, 2005
Last Updated: September 20, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ludwig Institute for Cancer Research:
Malignant melanoma
Stages IIB-III

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 30, 2014