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NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant

Phase 1
18 Years
Not Enrolling
Malignant Melanoma

Thank you

Trial Information

NY-ESO-1 Protein Vaccination in Malignant Melanoma Administered With Imiquimod as Adjuvant

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Nina Bhardwaj, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Food and Drug Administration

Study ID:

NYU 04-53, LUD2004-006



Start Date:

August 2005

Completion Date:

June 2007

Related Keywords:

  • Malignant Melanoma
  • Malignant melanoma
  • Stages IIB-III
  • Melanoma



NYU Cancer Institute New York, New York  10016