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

NCT00142454 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: LUD2004-006NYU 04-53
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity of treatment.

Conditions

Malignant Melanoma

Keywords

Malignant melanoma; Stages IIB-III

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Treatment-emergent Adverse Events (TEAEs)

  Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, from the time informed consent was signed through the last follow-up visit. AEs were considered to be treatment emergent (TEAE) if they occurred or worsened in severity after the first dose of study treatment.

  Up to 4 months

Secondary Outcomes (2)

• Number of Patients With Cellular Antibody Response to NY-ESO-1 at Two or More Post-vaccination Time Points

  Up to 4 months

• Number of Patients With Humoral Antibody Response to NY-ESO-1

  Up to 4 months

Study Arms (1)

Imiquimod + NY-ESO-1

EXPERIMENTAL

Patients applied topical imiquimod followed by vaccination with intradermal injections of the NY-ESO-1 protein.

Drug: Imiquimod; Biological: NY-ESO-1 protein

Interventions

Imiquimod DRUG

Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner thighs) in each cycle. The cream was to be rubbed into the skin until it was no longer visible. Patients were encouraged to wash their hands before and after applying cream. The application site was not occluded. The next morning, 6 to 10 hours after initial application, the treated area was washed with mild soap and water to remove any residual cream.

Also known as: Aldara

Imiquimod + NY-ESO-1

NY-ESO-1 protein BIOLOGICAL

NY-ESO-1 protein was injected intradermally by a study physician or nurse at a dose of 100 μg into the imiquimod-pretreated area on Day 3 of each cycle for 4 consecutive 21-day cycles.

Imiquimod + NY-ESO-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead
• Cancer Research Institute, New York City: collaborator

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

Location

Related Publications (1)

• Adams S, O'Neill DW, Nonaka D, Hardin E, Chiriboga L, Siu K, Cruz CM, Angiulli A, Angiulli F, Ritter E, Holman RM, Shapiro RL, Berman RS, Berner N, Shao Y, Manches O, Pan L, Venhaus RR, Hoffman EW, Jungbluth A, Gnjatic S, Old L, Pavlick AC, Bhardwaj N. Immunization of malignant melanoma patients with full-length NY-ESO-1 protein using TLR7 agonist imiquimod as vaccine adjuvant. J Immunol. 2008 Jul 1;181(1):776-84. doi: 10.4049/jimmunol.181.1.776.

  PMID: 18566444 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

(212) 450-1539

Study Officials

• Nina Bhardwaj, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Sylvia Adams, MD

  NYU Langone Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: August 24, 2005
• Primary Completion: April 25, 2006
• Study Completion: April 25, 2006
• Last Updated: October 10, 2022
• Results First Posted: October 22, 2020

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)