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NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors

NCT00299728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-10-10

Study results available
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Summary

This is a Phase I, open-label, randomized study of NY-ESO-l protein with immune adjuvants CpG 7909 and Montanide ISA-51 VG in patients with tumors that often express NY-ESO-1.

The vaccinations was to be administered subcutaneously every 3 weeks for 4 doses.

Patients with any malignancy that is known to frequently express NY-ESO-1 were eligible, regardless of whether antigen expression in the autologous tumor could be demonstrated or not by either PCR or immunohistochemistry.

The primary objective of the study was to define safety.

Secondarily, the study was to evaluate whether patients developed a specific immunologic response to the NY-ESO-1 protein. Blood samples were to be obtained at baseline, prior to each vaccination, one week after each vaccination, and at the last study visit for the assessment of NY-ESO-1-specific CD4+ and CD8+ T cells. Cytokine secretion by NY-ESO-1-specific CD8+ and CD4+ T cells, as a measure of T cell activation, was to be determined by FACS analysis. In addition, humoral immunity was to be determined by the presence of NY-ESO-1-specific antibodies which were to be assessed in all patients by ELISA.

Disease status was to be assessed at baseline and 2-4 weeks after the fourth vaccination in patients with evaluable (measurable and non-measurable) disease.

Conditions

Interventions

BIOLOGICAL

NY-ESO-1 Protein Vaccine

NY-ESO-1 recombinant protein mixed with CpG 7909 and Montanide ISA-51 VG

Sponsors & Collaborators

Principal Investigators

  • Nina Bhardwaj, MD, PhD · NYU Langone Health

  • Sylvia Adams, MD · NYU Langone Health

  • Gregory Mears, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-21
Primary Completion
2006-10-10
Completion
2014-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00299728 on ClinicalTrials.gov