NeoplasmsPhase 1NCT00106158
Safety Study of NY-ESO-1 Protein Vaccine to Treat Cancer Expressing NY-ESO-1
A Phase 1 study testing protein vaccination in people with Neoplasms, run by Ludwig Institute for Cancer Research at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1 specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients with cancer expressing NY-ESO-1. Read more about this study
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cancer
- Confirmed NY-ESO-1 expression
- No other effective therapy available
- 4 weeks since conventional therapy before start of the current protocol
- Performance status < 2 (ECOG scale)
- Age > 18
- Able and willing to give written informed consent
Who cannot join
- Serious illness
- Metastatic diseases to central nervous system
- Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or NSAIDs
- HIV positive
- Mental impairment that may compromise the ability to give written informed consent
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
Japan1 site
Dept. of Immunology, Okayama University School of Medicine and Dentistry
Okayama, 700-8558
About this study
Official title: Immunization of Patients With Tumors Expressing NY-ESO-1 or LAGE Antigen With Complex of NY-ESO-1 Protein and Cholesterol-bearing Hydrophobized Pullulan (CHP)
The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1 specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients with cancer expressing NY-ESO-1.
Read the detailed description
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries (SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse transcription-polymerase chain reaction (RT-PCR) analysis showed that NY-ESO-1 displayed the typical expression pattern of CT antigens. NY-ESO-1 mRNA was expressed only in testis of normal tissues tested and in various types of cancer, including lung cancer, breast cancer, malignant melanoma and bladder cancer. LAGE-1 was identified by the representational difference analysis and revealed to display 84% amino acid homology with NY-ESO-1. In most cases, expression of LAGE-1 parallels the expression of NY-ESO-1. Since testis is an immune privileged organ where HLA molecules are not expressed, these antigens can be considered tumor-specific.
Because of frequent NY-ESO-1 mRNA expression and high immunogenicity in advanced cancer, NY-ESO-1 is an attractive target molecule for a cancer vaccine. Current therapies against advanced cancer have limited effectiveness. The idea of vaccination with NY-ESO-1 protein in cancer patients with tumors expressing NY-ESO-1 mRNA is based on two findings: 1) the number of CD8+ T cell epitopes identified in NY-ESO-1 molecule are limited to those binding to HLA-A0201, A31, Cw3 and Cw6. These HLA subtypes are carried by a minor Japanese population; 2) CD8+ T cell responses specific to NY-ESO-1 are polyclonal. Protein vaccination may induce immune response more effectively against tumors expressing NY-ESO-1 than peptide immunization.
- Conditions
- Neoplasms
- Being tested
- protein vaccination
- Keywords
- cancer/testis antigen, cancer vaccine, recombinant protein
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein vaccinationBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
NY-ESO-1-specific immune responses
Secondary outcomes (1)
tumor responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2005 (estimated)
- Study startJun 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Institute for Cancer Research
- Sponsor type
- University, hospital or other
- Investigators
- Eiichi Nakayama, MD., PhD, Principal investigator, Dept. of Immunology, Okayama University Schhol of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106158
- Sponsor's protocol ID
- LUD2002-005
- Status last verified
- Aug 2007
- First submitted
- 21 Mar 2005
- Last updated
- 5 Nov 2010
- Results posted
- No
Publications
Sato S, Noguchi Y, Wada H, Fujita S, Nakamura S, Tanaka R, Nakada T, Hasegawa K, Nakagawa K, Koizumi F, Ono T, Nouso K, Jungbluth A, Chen YT, Old LJ, Shiratori Y, Nakayama E. Quantitative real-time RT-PCR analysis of NY-ESO-1 and LAGE-1a mRNA expression in normal tissues and tumors, and correlation of the protein expression with the mRNA copy number. Int J Oncol. 2005 Jan;26(1):57-63.
PubMed 15586225Sugita Y, Wada H, Fujita S, Nakata T, Sato S, Noguchi Y, Jungbluth AA, Yamaguchi M, Chen YT, Stockert E, Gnjatic S, Williamson B, Scanlan MJ, Ono T, Sakita I, Yasui M, Miyoshi Y, Tamaki Y, Matsuura N, Noguchi S, Old LJ, Nakayama E, Monden M. NY-ESO-1 expression and immunogenicity in malignant and benign breast tumors. Cancer Res. 2004 Mar 15;64(6):2199-204. doi: 10.1158/0008-5472.can-03-3070.
PubMed 15026363Nakada T, Noguchi Y, Satoh S, Ono T, Saika T, Kurashige T, Gnjatic S, Ritter G, Chen YT, Stockert E, Nasu Y, Tsushima T, Kumon H, Old LJ, Nakayama E. NY-ESO-1 mRNA expression and immunogenicity in advanced prostate cancer. Cancer Immun. 2003 Jul 31;3:10.
PubMed 12889868Fujita S, Wada H, Jungbluth AA, Sato S, Nakata T, Noguchi Y, Doki Y, Yasui M, Sugita Y, Yasuda T, Yano M, Ono T, Chen YT, Higashiyama M, Gnjatic S, Old LJ, Nakayama E, Monden M. NY-ESO-1 expression and immunogenicity in esophageal cancer. Clin Cancer Res. 2004 Oct 1;10(19):6551-8. doi: 10.1158/1078-0432.CCR-04-0819.
PubMed 15475443Kurashige T, Noguchi Y, Saika T, Ono T, Nagata Y, Jungbluth A, Ritter G, Chen YT, Stockert E, Tsushima T, Kumon H, Old LJ, Nakayama E. Ny-ESO-1 expression and immunogenicity associated with transitional cell carcinoma: correlation with tumor grade. Cancer Res. 2001 Jun 15;61(12):4671-4.
PubMed 11406534
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization of Patients With Tumors Expressing NY-ESO-1 or LAGE Antigen With Complex of NY-ESO-1 Protein and Cholesterol-bearing Hydrophobized Pullulan (CHP)
- ClinicalTrials.gov ID
- NCT00106158
- Acronym / sponsor ID
- LUD2002-005
- Conditions
- Neoplasms
- Keywords
- cancer/testis antigen, cancer vaccine, recombinant protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Ludwig Institute for Cancer ResearchUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety of repeated doses of cholesterol-bearing hydrophobized pullulan (CHP) and NY-ESO-1 protein (CHP-NY-ESO-1) and describe the NY-ESO-1 specific-humoral and cellular immune response to immunization with CHP-NY-ESO-1 in patients with cancer expressing NY-ESO-1.
Detailed description
NY-ESO-1 was isolated by serological analysis of recombinant cDNA expression libraries (SEREX), using tumor mRNA and autologous serum from an esophageal cancer patient. Reverse transcription-polymerase chain reaction (RT-PCR) analysis showed that NY-ESO-1 displayed the typical expression pattern of CT antigens. NY-ESO-1 mRNA was expressed only in testis of normal tissues tested and in various types of cancer, including lung cancer, breast cancer, malignant melanoma and bladder cancer. LAGE-1 was identified by the representational difference analysis and revealed to display 84% amino acid homology with NY-ESO-1. In most cases, expression of LAGE-1 parallels the expression of NY-ESO-1. Since testis is an immune privileged organ where HLA molecules are not expressed, these antigens can be considered tumor-specific.
Because of frequent NY-ESO-1 mRNA expression and high immunogenicity in advanced cancer, NY-ESO-1 is an attractive target molecule for a cancer vaccine. Current therapies against advanced cancer have limited effectiveness. The idea of vaccination with NY-ESO-1 protein in cancer patients with tumors expressing NY-ESO-1 mRNA is based on two findings: 1) the number of CD8+ T cell epitopes identified in NY-ESO-1 molecule are limited to those binding to HLA-A0201, A31, Cw3 and Cw6. These HLA subtypes are carried by a minor Japanese population; 2) CD8+ T cell responses specific to NY-ESO-1 are polyclonal. Protein vaccination may induce immune response more effectively against tumors expressing NY-ESO-1 than peptide immunization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proven cancer
- Confirmed NY-ESO-1 expression
- No other effective therapy available
- 4 weeks since conventional therapy before start of the current protocol
- Performance status < 2 (ECOG scale)
Key exclusion criteria (6 listed)
- Serious illness
- Metastatic diseases to central nervous system
- Concomitant systemic treatment with corticosteroids, anti-histaminic drugs or NSAIDs
- HIV positive
- Mental impairment that may compromise the ability to give written informed consent
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 |
|---|---|---|
| protein vaccination | Biological | – |
Primary outcome
NY-ESO-1-specific immune responses
1 secondary outcome
tumor responses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
- Background: PubMed 15586225Sato S, Noguchi Y, Wada H, Fujita S, Nakamura S, Tanaka R, Nakada T, Hasegawa K, Nakagawa K, Koizumi F, Ono T, Nouso K, Jungbluth A, Chen YT, Old LJ, Shiratori Y, Nakayama E. Quantitative real-time RT-PCR analysis of NY-ESO-1 and LAGE-1a mRNA expression in normal tissues and tumors, and correlation of the protein expression with the mRNA copy number. Int J Oncol. 2005 Jan;26(1):57-63.
- Background: PubMed 15026363Sugita Y, Wada H, Fujita S, Nakata T, Sato S, Noguchi Y, Jungbluth AA, Yamaguchi M, Chen YT, Stockert E, Gnjatic S, Williamson B, Scanlan MJ, Ono T, Sakita I, Yasui M, Miyoshi Y, Tamaki Y, Matsuura N, Noguchi S, Old LJ, Nakayama E, Monden M. NY-ESO-1 expression and immunogenicity in malignant and benign breast tumors. Cancer Res. 2004 Mar 15;64(6):2199-204. doi: 10.1158/0008-5472.can-03-3070.
- Background: PubMed 12889868Nakada T, Noguchi Y, Satoh S, Ono T, Saika T, Kurashige T, Gnjatic S, Ritter G, Chen YT, Stockert E, Nasu Y, Tsushima T, Kumon H, Old LJ, Nakayama E. NY-ESO-1 mRNA expression and immunogenicity in advanced prostate cancer. Cancer Immun. 2003 Jul 31;3:10.
- Background: PubMed 15475443Fujita S, Wada H, Jungbluth AA, Sato S, Nakata T, Noguchi Y, Doki Y, Yasui M, Sugita Y, Yasuda T, Yano M, Ono T, Chen YT, Higashiyama M, Gnjatic S, Old LJ, Nakayama E, Monden M. NY-ESO-1 expression and immunogenicity in esophageal cancer. Clin Cancer Res. 2004 Oct 1;10(19):6551-8. doi: 10.1158/1078-0432.CCR-04-0819.
- Background: PubMed 11406534Kurashige T, Noguchi Y, Saika T, Ono T, Nagata Y, Jungbluth A, Ritter G, Chen YT, Stockert E, Tsushima T, Kumon H, Old LJ, Nakayama E. Ny-ESO-1 expression and immunogenicity associated with transitional cell carcinoma: correlation with tumor grade. Cancer Res. 2001 Jun 15;61(12):4671-4.
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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.
Eiichi Nakayama, MD., PhD principal investigator
Dept. of Immunology, Okayama University Schhol of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing protein vaccination in people with Neoplasms, run by Ludwig Institute for Cancer Research at 1 site in Japan.
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 7 inclusion and 6 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 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NY-ESO-1-specific immune responses. 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 NCT00106158, which also lists 5 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 5 Nov 2010.