UMIN ID: UMIN000002001
Registered date:24/05/2009
Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Malignant solid tumors, Malignant lymphoma, Multiple Myeloma, Acute leukemia |
| Date of first enrollment | 2003/11/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed 12 times at weekly intervals. The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria from 1 to 3 weeks after 12th WT1 vaccination . |
Outcome(s)
| Primary Outcome | 1. Safety Evaluation by NCI-CTCAE ver 3.0 2. Efficacy Clinical response rate Disease control rate |
|---|---|
| Secondary Outcome | 1. QOL outcomes 2. Immune responses to WT1 |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 79years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. There is deep-seated active infection. 2,3 There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition(TPN) 5. There is expanded liver metastasis. 6. There are other malignancies. 7. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD). 8. Post allogeneic hematopoietic stem cell transplantation 9. Pregnant or lactating woman 10. There is severe psychiatric disorder. 11. Responsible doctors judged the patient inappropriate for the trial |
Related Information
| Primary Sponsor | Department of Cancer immunotherapy, Osaka University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Oka Yoshihiro |
| Address | 2-2, Yamada-oka, Suita City, Osaka, Japan Japan 565-9871 |
| Telephone | 06-6879-3676 |
| yoshi@cit.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Department of Cancer Immunotherapy |
| scientific contact | |
| Name | Haruo Sugiyama |
| Address | 1-7, Yamada-oka, Suita City, Osaka , Japan Japan |
| Telephone | 06-6879-2593 |
| sugiyama@sahs.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Department of Clinical Laboratory Science |