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

NCT00292045 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: LUD2003-0242004DR1380 (SwissMedic)KEK-StV-Nr. 01/04 (local EC)
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief 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

Prostate Cancer

Keywords

NY-ESO-1 protein, immunization, advanced prostate cancer

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 first dose of study treatment through the final 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 56 weeks

Secondary Outcomes (3)

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

  Up to 28 weeks

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

  Up to 28 weeks

• Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)

  Up to 32 weeks

Study Arms (1)

NY-ESO-1 protein + CpG 7909

EXPERIMENTAL

Patients received immunization with intradermal injections of the NY-ESO-1 protein combined with CpG 7909.

Biological: NY-ESO-1 protein/CpG 7909

Interventions

NY-ESO-1 protein/CpG 7909 BIOLOGICAL

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).

NY-ESO-1 protein + CpG 7909

Eligibility Criteria

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

You may qualify if:

• Patients were eligible for enrollment if they fulfilled the following criteria:
• High-risk Stage D1 or metastatic prostate cancer (D2), confirmed by review of histology.
• Fully recovered from surgery.
• Showed stable or progressive disease as assessed by X-ray, ultrasound, and/or computed tomography (CT) scans under hormonal and/or chemotherapeutic treatment, which had been administered for ≥ 3 months.
• Any pretreatment with chemo- or radiotherapy must have been discontinued for ≥ 4 weeks prior to the first dose of study agent. Hormone therapy was allowed before and throughout the study.
• Expected survival of ≥ 3 months.
• Karnofsky performance status of ≥ 70%.
• Within the last 2 weeks prior to study day 1, vital laboratory parameters should have been within the normal range, except for the following laboratory parameters, which should have been within the ranges specified:
• Leukocytes \> 3,000/µl.
• Lymphocytes \> 700/µl.
• Platelets \> 100,000/µl.
• Serum creatinine \< 2.5 mg/dL.
• Alanine aminotransferase, aspartate aminotransferase, and total bilirubin \< 2.5 x upper limit of normal.
• Age ≥ 18 years.
• Able to give valid written informed consent.

You may not qualify if:

• Patients were excluded from the study if they fulfilled any of the following criteria:
• Clinically significant heart disease (i.e., New York Heart Association Class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
• Other serious illnesses, e.g., active infections requiring antibiotics, bleeding disorders.
• Concomitant systemic treatment with corticosteroids. Topical or inhalational steroids were permitted.
• Metastatic disease to the central nervous system.
• Mental impairment, in the opinion of the Investigator, that may have compromised the ability to give informed consent and comply with the requirements of the study.
• Lack of availability for immunological and clinical follow-up assessments.
• Participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
• Being a recipient of an organ or bone marrow allograft. Having an autoimmune disease other than vitiligo, such as, but not limited to, inflammatory bowel disease or multiple sclerosis.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead

Study Sites (2)

Krankenhaus Nordwest

Frankfurt, Germany

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

Related Publications (2)

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

• Karbach J, Neumann A, Atmaca A, Wahle C, Brand K, von Boehmer L, Knuth A, Bender A, Ritter G, Old LJ, Jager E. Efficient in vivo priming by vaccination with recombinant NY-ESO-1 protein and CpG in antigen naive prostate cancer patients. Clin Cancer Res. 2011 Feb 15;17(4):861-70. doi: 10.1158/1078-0432.CCR-10-1811. Epub 2010 Dec 16.

  PMID: 21163871 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

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

jskipper@lcr.org

(212) 450-1539

Study Officials

• Alexander Knuth, MD

  Clinic of Oncology, University Hospital Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

• Elke Jäger, MD, PhD

  II. Medizinische Klinik, Hämatologie/Onkologie, Krankenhaus Nordwest, Frankfurt

  PRINCIPAL INVESTIGATOR

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: February 13, 2006
• First Posted: February 15, 2006
• Study Start: October 27, 2004
• Primary Completion: January 9, 2006
• Study Completion: January 9, 2006
• Last Updated: October 4, 2023
• Results First Posted: January 27, 2021

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)