A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Phase 1
- Conditions
- pancreatic and biliary tumors
- Registration Number
- JPRN-UMIN000004063
- Lead Sponsor
- Department of Internal medicine, Division of Gastroenterology and Hepatology, Kashiwa Hospital, Jikei University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1. There is deep-seated active infection. 2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis. 3. Patients who have complications are considered in appropriate for the trial. 4. Dependent on total parenteral nutrition (TPN). 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodisplastic syndrome (MDS) and myeloproliferative disorders (MDP). 7. Pregnant or lactating woman. 8. Past history of severe drug allergy. 9. There is severe psychiatric disease. 10. Responsible doctor's judged the patient inappropriate for the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Toxicities and adverse events are defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
- Secondary Outcome Measures
Name Time Method 1. Clinical response rate Disease control rate Clinical benefit response 2. QOL outcomes 3. Immune responses to WT1