Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer
|First Submitted Date ICMJE||February 13, 2006|
|First Posted Date ICMJE||February 15, 2006|
|Last Update Posted Date||June 22, 2009|
|Start Date ICMJE||December 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00292045 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer|
|Official Title ICMJE||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|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Prostate Cancer|
|Intervention ICMJE||Biological: NY-ESO-1 protein/CpG|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Germany, Switzerland|
|Removed Location Countries|
|NCT Number ICMJE||NCT00292045|
|Other Study ID Numbers ICMJE||LUD2003-024
KEK-StV-Nr. 01/04 (local EC)
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Ludwig Institute for Cancer Research|
|Collaborators ICMJE||Not Provided|
|PRS Account||Ludwig Institute for Cancer Research|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP