Phase 1/2 clinical trial of the intratumoral administration of oncolytic virus for unresectable pancreatic cancer
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000039854
- Lead Sponsor
- Kagoshima University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
1) Patients with the following complications: Severe heart disease, severe respiratory disease, severe digestive disease, severe liver disease, uncontrolled diabetes, and infection requiring continuous treatment 2) Patients with a history of penicillin or allergy to pigs or cattle (including milk). 3) Patients with a disease that requires the administration of systemic immunosuppressants or steroids. 4) For patients judged to have failed the primary therapy of radiation or chemoradiation, the interval after the therapy is <= 1 month (patients are still eligible if the reason for primary therapy failure is progression of pancreatic cancer). 5) Patients with other currently active cancers (patients are still eligible if the other cancers are basal cell carcinoma, carcinoma in situ, superficial bladder cancer, or malignancies without metastasis or recurrence for more than five years and have been treated appropriately) 6) Patients with an uncontrollable fever or pain due to the tumor. 7) Patients with a history of gastroduodenal surgery or gastroduodenal stricture. 8) Patients who are pregnant, breast-feeding, or have a positive pregnancy test within one year after menopause. 9) Patients who received any other unapproved drug within four weeks before giving their consent. 10) Patients deemed inappropriate to include in the trial by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event, response rate
- Secondary Outcome Measures
Name Time Method Serum level of adenovirus, adenovirus excretion, antibody level of adenovirus, cytokine levels, rate of tumor size reduction, histological assessment, progression-free survival, overall survival