NIPH Clinical Trials Search

UMIN ID: UMIN000023579

Registered date:10/09/2016

WT1 Trio Peptide-vaccine for Rare Cancers

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedThymic cancer Thymoma Soft tissue sarcoma Malignant glioma Salivary gland cancer Head and neck mucoepidermoid carcinoma Olfactory neuroblastoma Head and neck mucosal malignant melanoma Ophthalmic malignant melanoma Cancer of the external auditory canal Testicular cancer Cancer of penis Adrenal cancer Malignant mesothelioma Cancer of the small intestine Merkel cell carcinoma Cutaneous lymphoma (Rare cancers listed above)
Date of first enrollment2016/10/01
Target sample size90
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A patient is vaccinated with Montanide ISA51-adjuvanted WT1 Trio cancer vaccine consisting of two WT1 CTL peptides (WT1-126 and WT1-235) and one WT1 HTL peptide (WT1-332) (2mg each) seven times at the interval of two weeks.


Primary OutcomeInduction of WT1-specific immune responses assessed by WT1-related tests such as WT1-DTH skin reaction and serum levels of WT1 peptide IgG autoantibody at 1M, 2M, and 3M of WT1 Trio vaccine.
Secondary OutcomeSafety (Occurrence of SAE during the vaccination period) Clinical efficacy (Tumor regression at 1M, 2M, and 3M of WT1 Trio vaccine, OS, PFS) Induction of immune responses (Frequency of WT1-CTLs in PB)

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteria1 A patient with active infectious disease. 2 A patient with severe complication or complications. 3 A patient with severe mental disorder. 4 A patient who participates in any other clinical trial 5 A patient who should not be recruited to the clinical trial as determined by the investigators

Related Information


public contact
Name Yusuke Oji
Address 2-2 Yamada-oka Suita Osaka, Japan Japan
Telephone 06-6879-3676
Affiliation Osaka University Graduate School of Medicine Dept. Cancer Immunotherapy
scientific contact
Name Yusuke OJI
Address 1-7 Yamada-oka Suita Osaka, Japan Japan
Telephone 06-6879-2597
Affiliation Osaka University Graduate School of Medicine Dept. Cancer Stem Cell Biology