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Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer

NCT00292045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-04

Study results available
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Summary

This was a Phase 1, open-label, fixed-dose study of immunization with the NY-ESO-1 protein combined with CpG 7909 as an adjuvant in patients with histopathologically confirmed, high-risk Stage D1 or advanced prostate cancer. The primary study objective was to assess the safety of NY-ESO-1 protein/CpG 7909 immunization, and the secondary objective was to evaluate the immunity induced by immunization.

Conditions

Interventions

BIOLOGICAL

NY-ESO-1 protein/CpG 7909

Patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) as an adjuvant administered intradermally every 3 weeks for 4 doses (i.e., 12-week cycle).

Sponsors & Collaborators

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Alexander Knuth, MD · Clinic of Oncology, University Hospital Zürich, Switzerland

  • Elke Jäger, MD, PhD · II. Medizinische Klinik, Hämatologie/Onkologie, Krankenhaus Nordwest, Frankfurt

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-27
Primary Completion
2006-01-09
Completion
2006-01-09
FDA Drug
Yes

Countries

  • Germany
  • Switzerland

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 NCT00292045 on ClinicalTrials.gov