Trials / Active Not Recruiting
Active Not RecruitingNCT01883297
"Re-Stimulated" TILs and IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase I Study Evaluating the Feasibility and Safety of Infusion of "Re-Stimulated" Autologous TILs Followed by Low-Dose IL-2 Therapy in Patients with Platinum Resistant High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I clinical study for patients with platinum-resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer, and the response to a combination of cyclophosphamide, autologous tumor-infiltrating lymphocytes (TILs), autologous dendritic cells (DCs), and OKT3 (anti-CD3 antibody), along with low-dose interleukin-2 (IL-2) therapy.
Detailed description
This is a phase I clinical study for patients with platinum-resistant (does not respond to platinum-based chemotherapy) high grade serous ovarian, fallopian tube, or primary peritoneal cancer. Prior to the main treatment, patients will receive cyclophosphamide by vein. Patients will then receive an infusion (given by vein) of autologous tumor-infiltrating lymphocytes (TILs) which will first be taken from the patient, then be stimulated with certain substances called autologous dendritic cells (DCs) and OKT3 (anti-CD3 antibody), and then given back to the patient as an infusion. This is believed to make the TILs work better. TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down. After infusion of TILs, low-dose interleukin-2 (IL-2) therapy will be given.
Conditions
- Recurrent
- Platinum-resistant
- High Grade Serous Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Re-stimulated tumor-infiltrating lymphocytes (TILs) | Intravenous infusions: Dose level 1 (3 patients): 3x10\^7 TILs (with maximum 3x10\^6 autologous dendritic cells); Dose level 2 (3 patients): 1x10\^8 TILs (with maximum 1x10\^7 autologous dendritic cells); Dose level 3 (3 patients): 3x10\^8 TILs (with maximum 3x10\^8 autologous dendritic cells) |
| BIOLOGICAL | Interleukin-2 | Subcutaneous injections of IL-2 x 4 days during the first week and x 5 days the second week with 2 days of rest in between each week of dosing |
| DRUG | Cyclophosphamide | Intravenous infusion: 30 mg/kg/day for 2 days (Day -3 and -2 prior to infusion of TILs) |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2013-06-21
- Last updated
- 2024-09-05
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01883297. Inclusion in this directory is not an endorsement.