UMIN ID: UMIN000001599
Registered date:25/12/2008
CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | MAGE-A4-expressing therapy-resistant cancer (non origin-limited) |
| Date of first enrollment | 2008/12/01 |
| Target sample size | 6 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram or 300 microgram,every two weeks, repeated at least six cycles |
Outcome(s)
| Primary Outcome | Safety:maximum-tolerable dose, dose-limting toxicity, profiles of adverse events. Efficacy: MAGE-A4-specific immune responses |
|---|---|
| Secondary Outcome | Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.HIV-positives. 2.Double cancers. 3.Autoimmune disease. 4.History of serious hypersensitivity. 5.Active CNS metastasis. 6.Lasting less than four weeks from the previous chemotherapy, systemic corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to primary tumors 7.Pregnant or lactating. 8.Inappropriate for study entry judged by an attending physician. |
Related Information
| Primary Sponsor | CHP-MAGE-A4 cancer vaccine study at Mie University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Mie University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shinichi Kageyama |
| Address | 2-174, Edobashi, Tsu, Mie, 514-8507 Japan Japan |
| Telephone | 059-231-5280 |
| kageyama@clin.medic.mie-u.ac.jp | |
| Affiliation | CHP-MAGE-A4 clinical trial registry Cancer vaccine, Mie Universituy |
| scientific contact | |
| Name | Hiroshi Shiku |
| Address | 2-174, Edobashi, Tsu, Mie, 514-8507 Japan Japan |
| Telephone | 059-231-5187 |
| kageyama@clin.medic.mie-u.ac.jp | |
| Affiliation | Mie University Graduate School of Medicine Immuno-Gene Therapy |