NIPH Clinical Trials Search

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) studiedMalignant solid tumors, Malignant lymphoma, Multiple Myeloma, Acute leukemia
Date of first enrollment2003/11/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
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 .


Primary Outcome1. Safety Evaluation by NCI-CTCAE ver 3.0 2. Efficacy Clinical response rate Disease control rate
Secondary Outcome1. QOL outcomes 2. Immune responses to WT1

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name Oka Yoshihiro
Address 2-2, Yamada-oka, Suita City, Osaka, Japan Japan 565-9871
Telephone 06-6879-3676
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
Affiliation Osaka University Graduate School of Medicine Department of Clinical Laboratory Science