Metastatic TumorsPhase 1peptidevacNCT00676949
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors
A Phase 1 study testing 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1 in people with Metastatic Tumors, run by Kyushu University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Metastatic Tumors
- What is being tested?
- 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2007to Mar 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of unresectable or relapsed gastrointestinal, lung or cervical cancer patients
- performance status 0-1
- age between 20 and 80
- at least 4 weeks after previous therapy
- life expectancy more than 3 months
- permissible bone marrow, liver and renal function
- HLA-A2402
- no viral hepatitis, HIV or HTLV1
Who cannot join
- severe underlying disease
- pregnant or lactating women
- active brain metastasis
- uncontrollable infection
- under systemic corticosteroid or immune suppressant treatment
- history of allergy to epitope peptides or IFA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)
The purpose of this study is to evaluate the clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers
Read the detailed description
KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression profile analysis by the use of cDNA microarray in the previous studies. The investigators have determined the HLA-A*2402 restricted epitope peptides respectively derived from KOC1, TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated with the appropriate targets expressing the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore the investigators focused on the prevention of further expansion of the solid tumors highly expressing these 5 proteins using these 5 peptides.
- Conditions
- Metastatic Tumors
- Being tested
- 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1
- Keywords
- epitope peptide, cyclophosphamide, interleukin-2
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1Biological
Also called 5 peptide cocktail
1mg each of 5 peptides with IFA. 4 weekly s.c. administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | cyclophosphamide dose escalation, level 1:150mg/m2,level 2: 300mg/m2, level 3: 300mg/m2x2, with 5 kinds o tumor specific antigen peptides followed by low dose IL-2, 6 patients will be enrolled for each level. Receives: Biological: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
Measured: 2 years
Secondary outcomes (1)
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startNov 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic TumorsStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyushu University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Investigators
- Kenzaburo Tani, MD,phD, Principal investigator, Medical Institute of Bioregulation, Kyushu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676949
- Sponsor's protocol ID
- KU-CY5peptides
- Other IDs
- 19-40
- Acronym
- peptidevac
- Status last verified
- Apr 2011
- First submitted
- 3 Mar 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wada 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 15930316
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)
- ClinicalTrials.gov ID
- NCT00676949
- Acronym / sponsor ID
- peptidevac / KU-CY5peptides
- Conditions
- Metastatic Tumors
- Keywords
- epitope peptide, cyclophosphamide, interleukin-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kyushu UniversityUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- Nov 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 May 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 clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers
Detailed description
KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression profile analysis by the use of cDNA microarray in the previous studies. The investigators have determined the HLA-A*2402 restricted epitope peptides respectively derived from KOC1, TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated with the appropriate targets expressing the appropriate protein and HLA-A*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore the investigators focused on the prevention of further expansion of the solid tumors highly expressing these 5 proteins using these 5 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: 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1cyclophosphamide dose escalation, level 1:150mg/m2,level 2: 300mg/m2, level 3: 300mg/m2x2, with 5 kinds o tumor specific antigen peptides followed by low dose IL-2, 6 patients will be enrolled for each level. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- clinical diagnosis of unresectable or relapsed gastrointestinal, lung or cervical cancer patients
- performance status 0-1
- age between 20 and 80
- at least 4 weeks after previous therapy
- life expectancy more than 3 months
Key exclusion criteria (6 listed)
- severe underlying disease
- pregnant or lactating women
- active brain metastasis
- uncontrollable infection
- under systemic corticosteroid or immune suppressant treatment
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 |
|---|---|---|
| 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1Also: 5 peptide cocktail1mg each of 5 peptides with IFA. 4 weekly s.c. administration. | Biological | 1 |
Primary outcome
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail
Time frame: 2 years
1 secondary outcome
immunological efficacies and clinical efficacies of the cyclophosphamide combined tumor specific epitope peptides cocktail
Time frame: 2.5 years
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 23 Jun 2011.
- 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.
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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.
Kenzaburo Tani, MD,phD principal investigator
Medical Institute of Bioregulation, Kyushu University
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 5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1 in people with Metastatic Tumors, run by Kyushu 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 8 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 23 Jun 2011. 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?
safety of the cyclophosphamide combined tumor specific epitope peptide cocktail (time frame: 2 years). 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 NCT00676949, which also lists 1 linked publication.
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 23 Jun 2011.