UMIN ID: UMIN000001426
Registered date:01/11/2008
Phase I/IIa trial of autologous tumor vaccine and temozolomide administration in patients with primary glioblastoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Glioblastoma |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 25 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Autologous tumor vaccination |
Outcome(s)
| Primary Outcome | Overall survival |
|---|---|
| Secondary Outcome | Cause-specific survival Progression-free survival Tumor-regression rate, disease-control rate QOL Neurological improvement |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients who have been administered or are taking corticosteroid or anticancer drugs. 2) Patients with high intracranical pressure. 3) Patients with severe myelosupression. 4) Patients with severe complication including hematopathy 5) Patients with malignant tumor or cancer. 6) Pregnant or nursing woman, or woman willing to be pregnant. 7) Patients participate in other study during or within 6 months before temozolomide administration in this study. 8) Other reasons for exclusion |
Related Information
| Primary Sponsor | University of Tsukuba |
|---|---|
| Secondary Sponsor | Tokyo Womens Medical University |
| Source(s) of Monetary Support | Cell Medicine Cooperation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Eiichi Ishikawa |
| Address | Tennodai 1-1-1, Tsukuba, Ibaraki, Japan Japan |
| Telephone | 029-853-3220 |
| e-ishikawa@md.tsukuba.ac.jp | |
| Affiliation | University of Tsukuba Department of Neurosurgery, Doctoral Program in Functional and Regulatory Medical Science, Graduate |
| scientific contact | |
| Name | Eiichi Ishikawa |
| Address | 1-1-1 Tennodai, Tsukuba City, Ibaraki Japan |
| Telephone | 029-853-3220 |
| e-ishikawa@md.tsukuba.ac.jp | |
| Affiliation | University of Tsukuba Department of Neurosurgery, Neurological Institute |