VAC-XAGE Clinical Trial

JRCT ID: jRCTs061180010

Registered date:11/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Advanced lung adenocarcinoma
• Date of first enrollment: 26/06/2017
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Each dose of vaccine 0.25mg,0.5mg,and 1mg is given to three patients,and their safety is evaluated.

Outcome(s)

• Primary Outcome: Safety: type, frequency, degree of adverse event
• Secondary Outcome: XAGE1 antibody respose

Key inclusion & exclusion criteria

• Age minimum: 20<=
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Oka Mikio
• Source(s) of Monetary Support: Pole Star Co. Ltd.
• Secondary ID(s): UMIN000026493