Non Small Cell Lung CancerPhase 1NCT00633724
Multiple-Vaccine Therapy in Treating Patients With Non-small Cell Lung Cancer
A Phase 1 study testing HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2 in people with Non Small Cell Lung Cancer, run by Fukushima Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteJapan
- Study dates
- May 2007to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease characteristics
- Advanced or recurrent non small cell lung cancer
- Second line or later therapeutic status
- Patient characteristics
- ECOG performance status 0-2
- Life expectancy > 3 months
Show all 9Show fewer
- HLA-A*2402
- Laboratory values as follows 1500/mm3<WBC<15000/mm3 Platelet count>75000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 99IU/L Alanine transaminase < 126IU/L Creatinine < 2.2mg/dl
- Able and willing to give valid written informed consent
Who cannot join
- Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
- Pregnancy (woman of child bearing potential)
- Active and uncontrolled infectious disease
- Adrenal cortical steroid hormone dependent status
- Decision of unsuitableness by principal investigator
Trial locations and contacts
1 site in 1 country.
Japan1 site
Fukushima Medical University Hospital
Fukushima, Fuskushima, 960-1295
About this study
Official title: Phase I Study of Multiple-vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent Non-small Cell Lung Cancer
The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
Read the detailed description
URLC10 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2Biological
Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 0.5mg, 1.0mg and 3.0mg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment
Measured: 3 months
Secondary outcomes (3)
Peptides specific CTL responses in vitro
Measured: 3 months
Objective response rate as assessed using RECIST criteria
Measured: 6 months
Changes in levels of regulatory T cells
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMay 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fukushima Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Responsible party
- Principal investigator, Hiroyuki Suzuki, Fukushima Medical University
- Investigators
- Mitsukazu Gotoh, MD,PhD, Study chair, Fukushima Medical University, First department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633724
- Sponsor's protocol ID
- FVT-L0701
- Status last verified
- Aug 2013
- First submitted
- 20 Feb 2008
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x.
PubMed 16630140Uchida N, Tsunoda T, Wada S, Furukawa Y, Nakamura Y, Tahara H. Ring finger protein 43 as a new target for cancer immunotherapy. Clin Cancer Res. 2004 Dec 15;10(24):8577-86. doi: 10.1158/1078-0432.CCR-04-0104.
PubMed 15623641Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
PubMed 17020992Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
PubMed 15930316Watanabe T, Suda T, Tsunoda T, Uchida N, Ura K, Kato T, Hasegawa S, Satoh S, Ohgi S, Tahara H, Furukawa Y, Nakamura Y. Identification of immunoglobulin superfamily 11 (IGSF11) as a novel target for cancer immunotherapy of gastrointestinal and hepatocellular carcinomas. Cancer Sci. 2005 Aug;96(8):498-506. doi: 10.1111/j.1349-7006.2005.00073.x.
PubMed 16108831Suzuki H, Fukuhara M, Yamaura T, Mutoh S, Okabe N, Yaginuma H, Hasegawa T, Yonechi A, Osugi J, Hoshino M, Kimura T, Higuchi M, Shio Y, Ise K, Takeda K, Gotoh M. Multiple therapeutic peptide vaccines consisting of combined novel cancer testis antigens and anti-angiogenic peptides for patients with non-small cell lung cancer. J Transl Med. 2013 Apr 11;11:97. doi: 10.1186/1479-5876-11-97.
PubMed 23578144
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Multiple-vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00633724
- Acronym / sponsor ID
- FVT-L0701
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Fukushima Medical UniversityUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- May 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Mar 2008 (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 evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
Detailed description
URLC10 and TTK have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Disease characteristics
- Advanced or recurrent non small cell lung cancer
- Second line or later therapeutic status
- Patient characteristics
- ECOG performance status 0-2
Key exclusion criteria (5 listed)
- Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
- Pregnancy (woman of child bearing potential)
- Active and uncontrolled infectious disease
- Adrenal cortical steroid hormone dependent status
- Decision of unsuitableness by principal investigator
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 |
|---|---|---|
| HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 0.5mg, 1.0mg and 3.0mg. | Biological | 1 |
Primary outcome
Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment
Time frame: 3 months
3 secondary outcomes
Peptides specific CTL responses in vitro
Time frame: 3 months
Objective response rate as assessed using RECIST criteria
Time frame: 6 months
Changes in levels of regulatory T cells
Time frame: 3 months
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 15 Aug 2013.
- Background: PubMed 16630140Suda T, Tsunoda T, Uchida N, Watanabe T, Hasegawa S, Satoh S, Ohgi S, Furukawa Y, Nakamura Y, Tahara H. Identification of secernin 1 as a novel immunotherapy target for gastric cancer using the expression profiles of cDNA microarray. Cancer Sci. 2006 May;97(5):411-9. doi: 10.1111/j.1349-7006.2006.00194.x.
- Background: PubMed 15623641Uchida N, Tsunoda T, Wada S, Furukawa Y, Nakamura Y, Tahara H. Ring finger protein 43 as a new target for cancer immunotherapy. Clin Cancer Res. 2004 Dec 15;10(24):8577-86. doi: 10.1158/1078-0432.CCR-04-0104.
- Background: PubMed 17020992Ishizaki H, Tsunoda T, Wada S, Yamauchi M, Shibuya M, Tahara H. Inhibition of tumor growth with antiangiogenic cancer vaccine using epitope peptides derived from human vascular endothelial growth factor receptor 1. Clin Cancer Res. 2006 Oct 1;12(19):5841-9. doi: 10.1158/1078-0432.CCR-06-0750.
- Background: PubMed 15930316Wada S, Tsunoda T, Baba T, Primus FJ, Kuwano H, Shibuya M, Tahara H. Rationale for antiangiogenic cancer therapy with vaccination using epitope peptides derived from human vascular endothelial growth factor receptor 2. Cancer Res. 2005 Jun 1;65(11):4939-46. doi: 10.1158/0008-5472.CAN-04-3759.
- Background: PubMed 16108831Watanabe T, Suda T, Tsunoda T, Uchida N, Ura K, Kato T, Hasegawa S, Satoh S, Ohgi S, Tahara H, Furukawa Y, Nakamura Y. Identification of immunoglobulin superfamily 11 (IGSF11) as a novel target for cancer immunotherapy of gastrointestinal and hepatocellular carcinomas. Cancer Sci. 2005 Aug;96(8):498-506. doi: 10.1111/j.1349-7006.2005.00073.x.
- Derived from this study: PubMed 23578144Suzuki H, Fukuhara M, Yamaura T, Mutoh S, Okabe N, Yaginuma H, Hasegawa T, Yonechi A, Osugi J, Hoshino M, Kimura T, Higuchi M, Shio Y, Ise K, Takeda K, Gotoh M. Multiple therapeutic peptide vaccines consisting of combined novel cancer testis antigens and anti-angiogenic peptides for patients with non-small cell lung cancer. J Transl Med. 2013 Apr 11;11:97. doi: 10.1186/1479-5876-11-97.
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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.
Mitsukazu Gotoh, MD,PhD study chair
Fukushima Medical University, First department of Surgery
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 HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2 in people with Non Small Cell Lung Cancer, run by Fukushima Medical University 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 9 inclusion and 5 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 15 Aug 2013. 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?
Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment (time frame: 3 months). 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 NCT00633724, which also lists 6 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 15 Aug 2013.