Safety and Efficacy Study of Epitope Peptide To Treat HLA-A*24 or A*02-positive Advanced Solid Tumors
NCT ID: NCT01949688
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2010-06-30
2019-03-31
Brief Summary
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Detailed Description
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In this phase I/II trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402 or HLA-A\*0201-positive advanced solid tumor patients who are refractory to standard therapy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HLA-A*2402 restricted peptides
HLA-A\*2402 restricted peptides with adjuvant
HLA-A*2402 or A*0201 restricted peptides
Open Label, Non-Randomized, Safety/Efficacy study:
1. HLA-A\*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A\*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
2. HLA-A\*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A\*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
HLA-A*0201 restricted peptides
HLA-A\*0201 restricted peptides with adjuvant
HLA-A*2402 or A*0201 restricted peptides
Open Label, Non-Randomized, Safety/Efficacy study:
1. HLA-A\*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A\*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
2. HLA-A\*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A\*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
Interventions
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HLA-A*2402 or A*0201 restricted peptides
Open Label, Non-Randomized, Safety/Efficacy study:
1. HLA-A\*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A\*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
2. HLA-A\*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A\*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status 0-1
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 10000/mm3 Platelet count \> 75000/mm3 15% \< Lymphcyte fraction Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*2402 or HLA-A\*0201
9. Able and willing to give valid written informed consent
Exclusion Criteria
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
20 Years
85 Years
ALL
No
Sponsors
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Tokyo University
OTHER
Shiga University
OTHER
Responsible Party
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Yataro Daigo
Professor
Principal Investigators
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Yataro Daigo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shiga University
Locations
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Shiga University of Medical Science Hospital
Ohtsu, Shiga, Japan
Countries
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Other Identifiers
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22-15
Identifier Type: OTHER
Identifier Source: secondary_id
SUMS-22-15
Identifier Type: -
Identifier Source: org_study_id
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