NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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.

Outcome(s)

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 criteria1 A patient with a malignancy below that is diagnosed histologically. Thymic cancer, Stage III, IV Thymoma, Stage III, IV Soft tissue sarcoma, recurrent or advanced Malignant glioma, recurrent or advanced salivary gland cancer, recurrent or advanced Head and neck mucoepidermoid carcinoma, recurrent or advanced Olfactory neuroblastoma, recurrent or advanced Head and neck mucosal malignant melanoma, recurrent or advanced Ophthalmic malignant melanoma, recurrent or advanced Cancer of the external auditory canal, recurrent or advanced testicular cancer, recurrent or advanced, and refractory, or treatment intolerant cancer of penis, recurrent or advanced adrenal cancer, recurrent or advanced malignant mesothelioma, recurrent or advanced cancer of the small intestine, recurrent or advanced, and refractory, or treatment intolerant Merkel cell carcinoma, recurrent or advanced Cutaneous lymphoma, recurrent or advanced 2 A patient with an advanced or refractory disease or who rejected a standard therapy 3 WT1 expression in the tumor as determined by immunohistochemistry 4 A patient with HLA-A-24:02 or HLA-A-02:01 5 A patient with measurable tumor or tumors 6 A patient without progressive metastatic brain tumors. * This should be confirmed by CT or MRI imaging. 7 Age; 16-85 years-old. 8 ECOG Performance Status, PS :0-1. PS 2 is allowed in case with primary brain tumor if it is ascribed to neural dysfunctions caused by brain tumor. 9 A patient without severe dysfunctions in his/her vital organs 10 A patient without uncontrolled pleural effusion, ascites, or cardiac effusion 11 Life longer than 6 months is expected. 12 Written informed consent is obtained.
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

Contact

public contact
Name Yusuke Oji
Address 2-2 Yamada-oka Suita Osaka, Japan Japan
Telephone 06-6879-3676
E-mail clinical-trial@cit.med.osaka-u.ac.jp
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
E-mail oji@sahs.med.osaka-u.ac.jp
Affiliation Osaka University Graduate School of Medicine Dept. Cancer Stem Cell Biology