VAC-XAGE Clinical Trial
- Conditions
- Advanced lung adenocarcinoma
- Registration Number
- JPRN-jRCTs061180010
- Lead Sponsor
- Oka Mikio
- Brief Summary
We confirmed the safety and augmentation effect in antibody responses of XAGE1 long-peptide vaccine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Advanced lung adenocarcinoma patient who meet all of the following criteria during enrollment.
1)Patients with refractory or intolerable to standard therapy, patients who have no standard therapy or refuse standard therapy.
2)Performance status 0-2
3)Patients should be 20 years or older at informed consent.
4)Patients did not received treatment (surgery, chemotherapy, radiotherapy, hyperthermia, other immunotherapy etc.) within 4 weeks.
5)Life expectancy >=3 months
6)No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions.
*WBC count:>=1,500/mm3
*Hemoglobin:>=8.0g/dl
*Platelet count:>=100,000/mm3
*Serum total bilirubin:<=1.5 mg/dl
*AST and ALT:<=2.5xULN
*Serum creatinine:<=1.5xULN
7)XAGE1 expression or XAGE1 antibody positive advanced lung adenocarcinoma
8)Given written informed consent.
9)Without the history of penicillin hypersensitivity.
1)Patients with HIV antibody.
2)Patients with HCV antibody and HCV-RNA detected by real-time PCR.
3)Patients with HBs antigen, HBs antibody, HBc antibody and HBV-DNA detected by real-time PCR.
4)Patients with active autoimmune disease.
5)History of serious anaphylaxis induced by antibody preparation.
6)Patients who have received or will receive vaccines of live or attenuated vaccines within 4 weeks of study drug administration.
7)Patients with double cancer.
8)Patients who have received continuous systemic corticosteroid, immunosuppressive drugs within 4 weeks.
9)Refuse to use birth control including condom etc. from the time of obtaining the first consent to 6 months after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
10)Patients with active infection, active inflammatory disease or suspected infection due to clinical symptoms such as fever.
11)Patients with psychosis or dementia.
12)Patients who have received hematopoietic stem cell transplantation.
13)Any other inadequacy for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: type, frequency, degree of adverse event
- Secondary Outcome Measures
Name Time Method XAGE1 antibody respose