UMIN ID: UMIN000023579
Registered date:10/09/2016
WT1 Trio Peptide-vaccine for Rare Cancers
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Thymic 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 enrollment | 2017/03/31 |
| Target sample size | 90 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| 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 Outcome | Induction 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 Outcome | Safety (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 minimum | 16years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1 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
| Primary Sponsor | Osaka University Graduate School of Medicine Dept. Cancer Immunotherapy |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Self funding,Ministry of science and technology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yusuke Oji |
| Address | 2-2 Yamada-oka Suita Osaka, Japan Japan |
| Telephone | 06-6879-3676 |
| 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 |
| oji@sahs.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Dept. Cancer Stem Cell Biology |