A phase III/IV clinical study to assess the safety and efficacy of dendritic cell immunotherapy in advanced stage ovarian cancer.

A clinical trial to study the extended safety and efficacy of dendritic cell-based cancer immunotherapy in stage III recurrent serous type ovarian cancer or stage IV ovarian cancer having serum CA 125 positivity.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000596

Enrollment

Registered

2010-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Intravenous infusion: six monthly doses of autologous dendritic cells Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

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

Exclusion criteria: Autoimmune disease Liver disease having serum bilirubin more than 3mg% Renal disease having raised serum creatinine more than >2mg% HIV positive status

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Pattern of serum CA 125 level 2. Radiological evidence of disease stability 3. Clinical wellbeing of patient 4. Improvement in performance statusTimepoint: 1. At 3 months, 6 months and 1 year	—

Countries

India

Contacts

Public ContactDr. Sharmin Yaqin

Institute of Cellular Therapies

sharmin@dendriticcellresearch.com01202500111

Outcome results