Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
- Conditions
- Malignant solid tumors, Malignant lymphoma, Multiple Myeloma, Acute leukemia
- Registration Number
- JPRN-UMIN000002001
- Lead Sponsor
- Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety Evaluation by NCI-CTCAE ver 3.0 2. Efficacy Clinical response rate Disease control rate
- Secondary Outcome Measures
Name Time Method 1. QOL outcomes 2. Immune responses to WT1