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Cell Therapy

Autologous tumor infiltrating lymphocytes (TILs) for Mesothelioma

Phase 1 & 2

Waitlist Available

Led By Marcus Butler, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to sign and date the informed consent form.

Must have measurable stage I-IV malignant pleural mesothelioma at the time of investigational treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new way to treat cancer by infusing the patient's own white blood cells that have been altered to attack the tumor.

Eligible Conditions

Mesothelioma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total number of adverse events for each event reported and the severity and attribution to study therapy of each event

Secondary outcome measures

Percentage of patients with a clinical response to the study treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tumor Infiltrating lymphocytes (TILs)Experimental Treatment4 Interventions

Lymphodepleting preparative regimen: Cyclophosphamide, intravenously, at 60mg/kg/day x 2 days, and Fludarabine, intravenously at 25mg/m2/day x 5 days Autologous tumor infiltrating lymphocytes (TILs): Intravenously at 1x10^10 - 1.6x10^11 cells Low-dose interleukin-2: Subcutaneously at 125,000 IU/kg per day, for 2 weeks (2 days rest between each week).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

Autologous tumor infiltrating lymphocytes (TILs)

2015

Completed Phase 2

~10

Cyclophosphamide

FDA approved

Aldesleukin

FDA approved

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,481 Total Patients Enrolled

5 Trials studying Mesothelioma

1,600 Patients Enrolled for Mesothelioma

Marcus Butler, M.D.Principal InvestigatorPrincess Margaret Cancer Centre

3 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical treatments is Autologous tumor infiltrating lymphocytes (TILs) primarily utilized for?

"Autologous tumor infiltrating lymphocytes (TILs) are a typical treatment for multiple sclerosis, but have also been known to effectively treat leukemia, myelocytic and acute retinoblastoma and histiocytic lymphoma patients."

Answered by AI

Are more participants being recruited to this trial currently?

"According to records on clinicaltrials.gov, this particular medical trial is no longer recruiting participants and was last updated in April 2021. However, there are 1065 separate trials that are actively searching for patients at the moment."

Answered by AI

What is the aggregate count of participants in this investigation?

"This research program is not currently recruiting patients. The first listing was posted on June 1st, 2015 and the latest update came April 11th, 2021. For those searching for other trials, there are 152 available options that involve mesothelioma malignancy and 913 studies concerning Autologous tumor infiltrating lymphocytes (TILs)."

Answered by AI

Are there any other documented cases of Autologous tumor infiltrating lymphocytes (TILs) being utilized in clinical trials?

"Presently, 913 clinical investigations have been launched to assess the efficacy of Autologous tumor infiltrating lymphocytes (TILs). Of these trials 163 are in Phase 3. Philadelphia, Pennsylvania is where most of these studies take place; however, there are 28673 other sites running such tests."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TILs & Low-Dose IL-2 Therapy Following Cyclophosphamide and Fludarabine in Pleural Mesothelioma Patients

2015. "TILs & Low-Dose IL-2 Therapy Following Cyclophosphamide and Fludarabine in Pleural Mesothelioma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02414945.