Unique ID issued by UMIN | UMIN000002856 |
---|---|
Receipt number | R000003443 |
Scientific Title | Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy |
Date of disclosure of the study information | 2010/01/01 |
Last modified on | 2012/06/08 09:21:02 |
Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy
Phase I/II study of peptide vaccination in combination with TS-1 for metastatic colorectal cancer with KRAS genetic mutation
Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy
Phase I/II study of peptide vaccination in combination with TS-1 for metastatic colorectal cancer with KRAS genetic mutation
Japan |
colorectal cancer
Hematology and clinical oncology |
Malignancy
YES
Recommended doses (RD) of VEGFR1/2-derived peptide vaccines as well as concurrent TS-1 are determined in the first step of this study. DCR, RR, OS, DFS, TTP, and AE are estimated in the second step of this study.
Safety,Efficacy
First step (clinical phase I)
Primary Endpoint: RD
Second step (clinical phase II)
Primary Endpoint: DCR
First step (clinical phase I)
Secondary Endpoint: AE, immunological reactions by peptide vaccine (CTL, CD8, reg T)
Second step (clinical phase II)
Secondary Endpoint: RR, OS, PFS, TTF, AE, immunological reactions by peptide vaccine (CTL, CD8, reg T)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Vaccine | Gene |
KRAS genetic sequence, peptide vaccination, TS1
20 | years-old | <= |
Not applicable |
Male and Female
1. Pathologically diagnosed colorectal cancer
2. contains metastatic lesions that can be estimated by RECIST.
3. undertook first-line and second-line therapies that contained oxaliplatin and CPT-11.
4. contains tumor in which KRAS gene codon 12 or 13 is mutated.
5. HLA-A2402
6. PS=0 or 1 (ECOG)
7. written informed consent
8. WBC >= 3,000 and <=12,000
Platelet >=100,000/mm3
lymphocytes >=1,000
GOT(AST) <=100 IU/L
GPT(ALT) <=100 IU/L
Serum Creatinine<= 1.2 mg/dl
Total Bilirubin <=1.5 mg/dl
Creatinine clearance >=50 ml/min (Cock-Gault)
1. active double cancer(s)
2. undertook radiation therapy for abdominal lesions.
3. HIV-positive patients
4. sever comorbidity (intestinal obstruction, uncontrolled Diabetes M., uncontrolled hypertension, Angina P., liver cirrhosis, pneumonitis, emphysema, etc)
5. allergy for TS1
6. ascites or pleural effusion that needs to be treated
7. patients with bleeding
8. patients treated with fruitosin
9. pregnant woman
15
1st name | |
Middle name | |
Last name | Takahiro Mori |
Tohoku University Graduate School of Medicine
Cancer Center
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
22-717-7879
1st name | |
Middle name | |
Last name |
Tohoku University Hospital
Clinical oncology
022-717-7087
Devision of Clinical Oncology, Tohoku University Hospital
Devision of Clinical Oncology, Tohoku University Hospital
NO
東北大学病院
2010 | Year | 01 | Month | 01 | Day |
Unpublished
Completed
2009 | Year | 11 | Month | 30 | Day |
2009 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2009 | Year | 12 | Month | 07 | Day |
2012 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003443