A phase III/IV clinical study to assess the safety and efficacy of dendritic cell immunotherapy in advanced stage ovarian cancer.
Phase 3
- Registration Number
- CTRI/2010/091/000596
- Lead Sponsor
- Instutute of Cellular Therapies Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Adult females
Age between 18yrs to 65yrs
Serous ovarian cancer with CA125 positivity
In Remission
Performance status between 0 to 3 (ECOG)
Exclusion Criteria
Autoimmune disease
Liver disease having serum bilirubin more than 3mg%
Renal disease having raised serum creatinine more than >2mg%
HIV positive status
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Efficacy; dosing and spacingTimepoint: Safety and Efficacy at Baseline, immediate, after 1 week, after 3 weeks, after 3 months and after 6 months
- Secondary Outcome Measures
Name Time Method 1. Pattern of serum CA 125 level<br>2. Radiological evidence of disease stability<br>3. Clinical wellbeing of patient<br>4. Improvement in performance statusTimepoint: 1. At 3 months, 6 months and 1 year