Renal Cell CarcinomaPhase 1NCT01254838
Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
A Phase 1 study testing HLA-A02 restricted HIG2 in people with Renal Cell Carcinoma, run by Iwate Medical University.
Trial summary
The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- HLA-A02 restricted HIG2
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 2008to Dec 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
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments
- PATIENTS CHARACTERISTICS
- Patients who showed resistance to hormonal therapy and chemotherapy
- Histological diagnosis is adenocarcinoma
- HLA-A*0201/0206
- ECOG performance status of 0 to 2
Show all 10Show fewer
- Age ≥ 20 years, ≤80 years
- WBC≥ 2,000/mm³, ≤12000/mm³ hemoglobin≥ 8.0g/dl Platelet count ≥ 70000/mm³ AST, ALT ≤100 IU/l Total bilirubin ≤ 1.5 mg/dl Creatinine ≤ 1.0 mg/dl PaO2≥ 70mmHg
- life expectancy ≥ 3months
- Able and willing to give valid written informed consent
Who cannot join
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breastfeeding
- Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
- Serious infections requiring antibiotics
- Concomitant treatment with steroids or immunosuppressing agent
- Other malignancy difficult to control.
- Decision of unsuitableness by principal investigator or physician-in-charge
About this study
The purpose of this study is to evaluate the safety and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma
- Conditions
- Renal Cell Carcinoma
- Being tested
- HLA-A02 restricted HIG2
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-A02 restricted HIG2Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability
hematological and non-hematological adverse event
Measured: 2 years
Secondary outcomes (1)
CTL reaction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
Sponsor and investigators
- Lead sponsor
- Iwate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Investigators
- Tomoaki Fujioka, Study chair, Department of Urology, Iwate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254838
- Sponsor's protocol ID
- IMU-H20-30-P1
- Status last verified
- Nov 2008
- First submitted
- 2 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Peptide Vaccination for Patients With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01254838
- Acronym / sponsor ID
- IMU-H20-30-P1
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Iwate Medical UniversityUniversity, hospital or other
- Collaborators
- Human Genome Center, Institute of Medical Science, University of Tokyo
- Study start
- Nov 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Dec 2010 (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 and CTL reaction of novel peptide vaccination for advanced renal cell carcinoma
Study design
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DISEASE CHARACTERISTICS advanced renal cell carcinoma which already showed resistance to standard treatments
- PATIENTS CHARACTERISTICS
- Patients who showed resistance to hormonal therapy and chemotherapy
- Histological diagnosis is adenocarcinoma
- HLA-A*0201/0206
Key exclusion criteria (7 listed)
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breastfeeding
- Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
- Serious infections requiring antibiotics
- Concomitant treatment with steroids or immunosuppressing agent
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-A02 restricted HIG2 | Biological | – |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 years
hematological and non-hematological adverse event
1 secondary outcome
CTL reaction
Time frame: 2 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 7 Dec 2010.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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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.
Tomoaki Fujioka study chair
Department of Urology, Iwate Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLA-A02 restricted HIG2 in people with Renal Cell Carcinoma, run by Iwate Medical University.
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 10 inclusion and 7 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 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Participants with Adverse Events as a Measure of Safety and Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2010.