Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.

UMIN ID: UMIN000002141

Registered date:01/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-Small-Cell Lung Cancer
• Date of first enrollment: 2009/07/01
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (0.5mg for each) are administered four times once a week.
Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (1.0mg for each) are administered four times once a week.
Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (3.0mg for each) are administered four times once a week.

Outcome(s)

• Primary Outcome: Evaluation of safety and adverse effects of vaccination therapy and determination of the recommended dose for phase II trial

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1.Pregnancy 2.Breastfeeding 3.Concurrent treatment with steroids or immunosuppressing agent 4.No other malignancy requiring treatment 5.No curative traumatic wound 6.Decision of unsuitableness by principal investigator or physician-in-charge

Related Information

• Primary Sponsor: Department of Respiratory Medicine, Juntendo University School of Medicine
• Secondary Sponsor: Human Genome Center, Institute of Medical Science, University of Tokyo
• Source(s) of Monetary Support: Juntendo University School of Medicine,Human Genome Center, Institute of Medical Science, University of Tokyo