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Randomized, Double Blind, Placebo-controlled Topical Resiquimod Adjuvant for NY-ESO-1 Protein Vaccination

NCT00821652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-01-08

No results posted yet for this study

Summary

The study is designed to see if a course of injections containing the NY-ESO-1 protein (a tumor antigen, marker expressed by tumors); in combination with an immune stimulant (adjuvant) Montanide, with or without resiquimod (another adjuvant) is well tolerated and safe in patients with surgically resected Stage IIB, IIC, Stage III or Stage IV (AJCC criteria) melanoma, a tumor that expresses NY-ESO-1. In addition, this study is designed to see if the patient's body's defense (immune) system can be boosted (strengthened) by this vaccine and if the addition of resiquimod to the vaccine makes this more likely.

Conditions

Interventions

DRUG

NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod

Part I: a cohort of 3 patients to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical resiquimod 1000 mg of the 0.2% gel on days 1, and 3. If no DLT observed, we will proceed to cohort 2 with Resiquimod dosing on days 1,3 and 5. If DLT is found in the second cohort, the trial will proceed to Part II; with the limited dosing for days 1 and 3 only, as used in the first cohort. If no DLT is found in second cohort, the trial will proceed to Part II with Resiquimod dosing for days1, 3 and 5.

DRUG

NY-ESO-1 protein; Montanide ISA®-51 VG; Resiquimod/placebo

Part II: Eligible patients will be randomized to receive a subcutaneous vaccination of 100µg NY-ESO-1 protein emulsified in 1.25mL Montanide ISA®-51 VG (day 1) followed by topical placebo gel (Arm A) or topical resiquimod gel (Arm B) on days 1, 3 and 5; or resiquimod dosing regimen established in Part I. The cycles will be repeated every 3 weeks for a total of 4 cycles (on Study week 1, 4, 7 and 10). All procedures may occur within + 3 days of the planned date.

Sponsors & Collaborators

  • Cancer Research Institute, New York City

    collaborator OTHER

  • Nina Bhardwaj

    lead OTHER

Principal Investigators

  • Nina Bhardwaj, MD, PhD · Icahn School of Medicine at Mount Sinai

  • Rachel Sabado, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-01-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821652 on ClinicalTrials.gov