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"Re-Stimulated" TILs and IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT01883297 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-09-05

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Marcus Butler, M.D. · Princess Margaret Cancer Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01883297 on ClinicalTrials.gov