Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00292045|
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : June 22, 2009
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: NY-ESO-1 protein/CpG||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Estimated Study Completion Date :||January 2006|
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292045
|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|