Prostate CancerPhase 1NCT00292045
Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer
A Phase 1 study testing NY-ESO-1 protein/CpG 7909 in people with Prostate Cancer, run by Ludwig Institute for Cancer Research at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- NY-ESO-1 protein/CpG 7909
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Oct 2004to 9 Jan 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the detailed description
Eligible patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) administered intradermally every 3 weeks for 4 doses. Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression. In patients with mixed response, single progressive lesions may have been resected and vaccination may have been continued.
Safety was monitored continuously. Blood samples were obtained for clinical hematology, biochemistry and immune response assessments, including antinuclear antibody (ANA) and anti-dsDNA, NY-ESO-1 and/or LAGE-1 specific antibodies, and NY-ESO-1 specific cluster of differentiation (CD)4+ and CD8+ T cells.
A tumor sample, resected prior to immunization, was tested to determine NY-ESO-1 and/or LAGE-1 expression. Delayed-type hypersensitivity (DTH) testing was performed at baseline and on study.
Disease status was assessed at baseline and on study in patients with measurable disease.
- Conditions
- Prostate Cancer
- Being tested
- NY-ESO-1 protein/CpG 7909
- Keywords
- NY-ESO-1 protein, immunization, advanced prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NY-ESO-1 protein/CpG 7909Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| NY-ESO-1 protein + CpG 7909 | Experimental | Patients received immunization with intradermal injections of the NY-ESO-1 protein combined with CpG 7909. Receives: Biological: NY-ESO-1 protein/CpG 7909 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 56 weeks
Secondary outcomes (3)
Number of Patients With Cellular Antibody Response to NY-ESO-1
Assays to assess cluster of differentiation (CD)4+ and CD8+ antigen-specific responses were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 4, 10, 16, 22, and 28) by enzyme-linked immune absorbent spot (ELISPOT) assay. A positive response was considered if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25.000 T cells or less if T-cell clones were used.
Measured: Up to 28 weeks
Number of Patients With Humoral Antibody Response to NY-ESO-1
Assays to assess NY-ESO-1 specific antibodies were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 4, 7, 10, 13, 16, 19, 22, 25, and 28). Sera were assessed over a range of dilutions from 1:100 to 1:400,000. Vaccine-induced antibodies were mapped with a panel of overlapping 20 mer peptides (25 μg/mL) spanning the whole protein sequence by enzyme-linked immunosorbent assay (ELISA). Immunoglobulin (Ig) subclasses G1 and G3 were determined by Western blot analysis using secondary antibody mouse anti-human IgG1/IgG3 at a dilution of 1:1000.
Measured: Up to 28 weeks
Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Appropriate imaging scans were performed at baseline (within 14 days prior to the first vaccination) and during the vaccination period (Weeks 13 and 28). Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
Measured: Up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study start27 Oct 2004
- Primary completion9 Jan 2006
- Study completion9 Jan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Knuth, MD, Principal investigator, Clinic of Oncology, University Hospital Zürich, SwitzerlandElke Jäger, MD, PhD, Principal investigator, II. Medizinische Klinik, Hämatologie/Onkologie, Krankenhaus Nordwest, Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292045
- Sponsor's protocol ID
- LUD2003-024
- Other IDs
- 2004DR1380 (SwissMedic), KEK-StV-Nr. 01/04 (local EC)
- Status last verified
- Oct 2023
- First submitted
- 13 Feb 2006
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10655437Karbach 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.
PubMed 21163871
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00292045
- Acronym / sponsor ID
- LUD2003-024
- Conditions
- Prostate Cancer
- Keywords
- NY-ESO-1 protein, immunization, advanced prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Study start
- 27 Oct 2004 (actual)
- Primary completion
- 9 Jan 2006 (actual)
- Study completion
- 9 Jan 2006 (actual)
- First posted
- 15 Feb 2006 (estimated)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible patients received vaccinations consisting of the NY-ESO-1 protein (100 µg) combined with CpG 7909 (2.5 mg) administered intradermally every 3 weeks for 4 doses. Patients who demonstrated stable disease, minor response, partial response, or complete response at Week 13 may have continued to receive vaccinations until disease progression. In patients with mixed response, single progressive lesions may have been resected and vaccination may have been continued.
Safety was monitored continuously. Blood samples were obtained for clinical hematology, biochemistry and immune response assessments, including antinuclear antibody (ANA) and anti-dsDNA, NY-ESO-1 and/or LAGE-1 specific antibodies, and NY-ESO-1 specific cluster of differentiation (CD)4+ and CD8+ T cells.
A tumor sample, resected prior to immunization, was tested to determine NY-ESO-1 and/or LAGE-1 expression. Delayed-type hypersensitivity (DTH) testing was performed at baseline and on study.
Disease status was assessed at baseline and on study in patients with measurable disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NY-ESO-1 protein + CpG 7909 | Experimental | Biological: NY-ESO-1 protein/CpG 7909Patients received immunization with intradermal injections of the NY-ESO-1 protein combined with CpG 7909. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NY-ESO-1 protein/CpG 7909Patients 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). | Biological | NY-ESO-1 protein + CpG 7909 |
Primary outcome
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 56 weeks
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.
3 secondary outcomes
Number of Patients With Cellular Antibody Response to NY-ESO-1
Time frame: Up to 28 weeks
Number of Patients With Humoral Antibody Response to NY-ESO-1
Time frame: Up to 28 weeks
Number of Patients With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10655437Therasse 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.
- Results publication: PubMed 21163871Karbach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Knuth, MD principal investigator
Clinic of Oncology, University Hospital Zürich, Switzerland
Elke Jäger, MD, PhD principal investigator
II. Medizinische Klinik, Hämatologie/Onkologie, Krankenhaus Nordwest, Frankfurt
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NY-ESO-1 protein/CpG 7909 in people with Prostate Cancer, run by Ludwig Institute for Cancer Research at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 56 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.