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

This study has been completed.
Sponsor:
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00292045
First received: February 13, 2006
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  Purpose

This is an open-label, fixed-dose study of immunization with NY-ESO-1 protein combined with CpG as adjuvant in patients with high-risk stage D1 or advanced prostate cancer

Eligible patients will receive vaccinations consisting of 100µg NY-ESO-1 protein combined with 2.5mg CpG administered intradermally every 3 weeks for 4 doses.


Condition Intervention Phase
Prostate Cancer
 Biological: NY-ESO-1 protein/CpG
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With High-Risk Stage D1 or Advanced Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ludwig Institute for Cancer Research:

Primary Outcome Measures:
  • to assess the safety of intradermal immunization with NY-ESO-1 protein combined with CpG 7909 in patients with high-risk stage D1 or advanced prostate cancer

Secondary Outcome Measures:
  • to evaluate the immunity induced after intradermal immunization with NY-ESO-1 protein combined with CpG 7909 in patients with high-risk stage D1 or advanced prostate cancer
  • to document tumor response following intradermal immunization with NY-ESO-1 protein combined with CpG 7909

Estimated Enrollment: 12
Study Start Date: December 2004
Estimated Study Completion Date: January 2006
Detailed Description:

This is an open-label, fixed-dose study of immunization with NY-ESO-1 protein combined with CpG 7909 as adjuvant in patients with histopathologically confirmed metastatic cancer of the prostate, who have progressive disease under hormonal and/or chemotherapeutic treatment (duration of treatment > 3 months).

Eligible patients will receive vaccinations consisting of 100µg NY-ESO-1 protein combined with 2.5 mg CpG 7909 administered intradermally every 3 weeks for 4 doses. Twelve (12) patients will be enrolled into this study.

Blood samples will be obtained at baseline, prior to the second, third and fourth injection and three weeks after the fourth injection for clinical hematology, biochemistry and immune response assessments. Blood samples for antinuclear antibody (ANA) and anti-dsDNA will be collected at baseline and end of each study cycle.

A tumor sample, resected prior to immunization, will be tested to determine NY-ESO-1 and/or LAGE-1 expression.

DTH testing will be performed with NY-ESO-1b in HLA-A2+ patients and with NY-ESO-1 DP4 in HLA-DP4+ patients at baseline and at the 3-week visit following the second and fourth vaccinations.

NY-ESO-1 and/or LAGE-1 specific antibodies will be assessed in all patients by Western Blot and ELISA. NY-ESO-1 specific CD4+ and CD8+ T cells will be assessed by ELISPOT analysis in all patients.

Disease status will be assessed at baseline and 3 weeks after the fourth vaccination in patients with measurable disease.

Patients who demonstrate stable disease, minor response, partial response, or complete response on week 13 may continue to receive vaccinations until disease progression. In patients with mixed response, single progressive lesions may be resected and vaccination may be continued.

Resected metastases should be typed for NY-ESO- and/or LAGE-1 expression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have high-risk stage D1 or metastatic prostate cancer (D2), confirmed by review of histology.
  2. Patients must have fully recovered from surgery.
  3. Patients must show stable or progressive disease as assessed by X-ray, ultrasound, and/or CT scans under hormonal and/or chemotherapeutic treatment, that had been administered for at least three months.
  4. Any pretreatment with chemo- or radiotherapy must have been discontinued for at least four weeks prior to first dose of study agent. Hormone therapy is allowed before and throughout the study.
  5. Patients must have an expected survival of at least three months.
  6. Patients must have a Karnofsky performance status of 70% or more.

  7. Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:

    • Leukocytes >3.000/ul
    • Lymphocytes >700/ul
    • Platelets >100.000/ul
    • Serum creatinine <2.5 mg/dl
    • ALT, AST, and total bilirubin all < 2.5 x ULN
  8. Age ≥ 18 years
  9. Able to give valid written informed consent.

Exclusion Criteria:

  1. Clinically significant heart disease (NYHA Class III or IV).
  2. Other serious illnesses, eg, active infections requiring antibiotics, bleeding disorders.
  3. Concomitant systemic treatment with corticosteroids. Topical or inhalational steroids are permitted.
  4. Metastatic disease to the central nervous system.
  5. Mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.
  6. Lack of availability for immunological and clinical follow-up assessments.
  7. Participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
  8. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292045

Locations
Germany
Krankenhaus Nordwest
Frankfurt, Germany
Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Investigators
Principal Investigator: Alexander Knuth, Prof. Dr. med. Clinic of Oncology, University Hospital Zürich, Switzerland
Principal Investigator: Elke Jäger, Prof. Dr. med. II. Medizinische Klinik, Hämatologie/Onkologie, Krankenhaus Nordwest, Frankfurt
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00292045     History of Changes
Other Study ID Numbers: LUD2003-024, 2004DR1380 (SwissMedic), KEK-StV-Nr. 01/04 (local EC)
Study First Received: February 13, 2006
Last Updated: June 19, 2009
Health Authority: Switzerland: Swissmedic
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig Institute for Cancer Research:
NY-ESO-1 protein, immunization, advanced prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013