Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer

Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer - Phase I/II clinical trial of WT1 peptide vaccine therapy for lung, breast, pancreas, stomach, and colorectal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011029

Enrollment

Registered

2013-07-01

Start date

2013-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung, breast, pancreas, stomach, and colorectal cancer

Interventions

Seven doses of HLA-A*24-restricted WT1 peptide (3 mg) emulsified with 1-2KE of OK-432 adjuvant will be intradermally injected on bilateral axillary and inguinal areas every 2 weeks. Injection schedule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically proven breast, lung, pancreas, stomach, or colorectal cancer. 2. Patients treated with operation, chemotherapy, and radiotherapy accoding to standard clinical guidelines. 3. Patients who did not received any specific immunotherapy before enrollment of this trial. 4. Patients enrolled the trial of WT1 pulsed dendritic cell therapy, but excluded due to the criteria of leukapheresis. 5. Patients with HLA-A*24 and having neither allergies to OK-432 nor to penicillin. 6. Patients aged 20 years or over at the time of informed concent. 7. Karnofsky performance status (KPS) are over 60%. 8. Estimated survival duration is over 3 months. 9. Function of major organs is maintained, with the following inclusion criteria. A) Leukocyte count>=3,000/mm3 B) Lymphocyte count>=500/ mm3 C) Platelet count>=100,000/mm3 D) Hemoglobin concentration >=10.0g/dL E) AST/ALT <2.5 x ULN F) Serum creatinine <=1.5 x ULN G) APTT/PT-INR <=1.5 x ULN

Exclusion criteria

Exclusion criteria: 1. Patients with severe organ dysfunction, infection under treatment, blood abnormalities or bleeding tendency. 2. Patients fulfilling the criteria of WT1 pulsed dendritic cell therapy are excluded from this trial

Design outcomes

Primary

Measure	Time frame
<Phase I portion> Ratios of adverse events <Phase II portion> PFS: Progression free survival, Overall survival	—

Secondary

Measure	Time frame
<Phase I portion> WT1 specific CTL rate in peripheral blood mononuclear cells (PBMCs), Lymphocyte subsets, WT1-specific interferon(IFN)-gamma production of PBMCs <Phase II portion> The ratio of the patients who completed the course, WT1 specific CTL rate in PBMCs, Lymphocyte subsets, WT1-specific IFN-gamma production of PBMCs	—

Countries

Japan

Contacts

Public ContactShigetaka Shimodaira

Shinshu University Hospital Center for Advanced Cellular Therapy

shimodai@shinshu-u.ac.jp0263-37-3220

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026