Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)
Phase 1
- Conditions
- Ovarian cancer,tubal carcinoma, primary peritoneal cancer
- Registration Number
- JPRN-UMIN000015233
- Lead Sponsor
- Tokyo Women's Medical University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 7
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who positive for anti-adult T-cell leukemia-associated antigen or anti-human immunodeficiency virus antibody,or hepatitis. 2)Patients who have uncontrolled infection 3)Patients receiving immunodepressant 4)Patient who were pregnant or lactating 5)Other patients judged to be ineligible by the attending investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of i.p. injection of autologous Gamma Delta T cells.
- Secondary Outcome Measures
Name Time Method Puncture-free-survival,QOL and immunological proof-of-concept of antitumor activity.