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Tumor-Infiltrating Lymphocytes and Low-Dose Interleukin-2 Therapy Following Cyclophosphamide and Fludarabine in Patients With Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT02414945
Recruitment Status : Recruiting
First Posted : April 13, 2015
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

This is a phase I and II clinical study for patients with malignant pleural mesothelioma (a type of cancer affecting the lining of the lung). Patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down.

Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy. This study will see how safe and useful this regimen is in treating malignant pleural mesothelioma.


Condition or disease Intervention/treatment Phase
Pleural Mesothelioma Drug: Cyclophosphamide Drug: Fludarabine Biological: Autologous tumor infiltrating lymphocytes (TILs) Biological: Interleukin-2 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study Evaluating the Infusion of Tumor-Infiltrating Lymphocytes (TILs) and Low-Dose Interleukin-2 (IL-2) Therapy Following a Preparative Regimen of Non-myeloablative Lymphodepletion Using Cyclophosphamide and Fludarabine in Patients With Malignant Pleural Mesothelioma
Study Start Date : June 2015
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : November 2025


Arm Intervention/treatment
Experimental: TILs

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).

Drug: Cyclophosphamide
Other Name: Procytox

Drug: Fludarabine
Other Name: Fludara

Biological: Autologous tumor infiltrating lymphocytes (TILs)
Biological: Interleukin-2
Other Name: Proleukin




Primary Outcome Measures :
  1. Total number of adverse events for each event reported and the severity and attribution to study therapy of each event [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Percentage of patients with a clinical response to the study treatment [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to sign and date the informed consent form.
  • Must have measurable stage I-IV malignant pleural mesothelioma at the time of investigational treatment.
  • May have 3 or fewer asymptomatic brain metastases.
  • Patient age: ≥ 18 years.
  • Clinical performance status of ECOG 0 or 1.
  • Life expectancy > 3 months from the date of consent.
  • Laboratory analyses of tumor-infiltrating lymphocytes (TILs) from the patient must demonstrate that the TILs are suitable for use in protocol treatment
  • More than 30 days has elapsed since any prior systemic therapy at the time of the cell infusion, or more than six weeks since prior nitrosurea therapy. All toxicities must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures with the past 3 weeks, as long as all toxicities have recovered to grade 1 or less
  • Adequate organ function
  • Women of child-bearing potential must have a negative pregnancy test. Patients of both genders must be willing to practice birth control during treatment and for 6 months post completion of IL-2 treatment.
  • Patients must have adequate respiratory function in the opinion of the treating thoracic physician

Exclusion Criteria:

  • Ongoing or prior use systemic steroid therapy within 4 weeks before the TILs infusion will be excluded.
  • Known HIV positive patients will be excluded.
  • Active hepatitis B or hepatitis C, syphilis, or HTLV will be excluded.
  • Must not have any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, uncontrolled psychiatric disorders, or other conditions that may affect compliance with the trial.
  • Must have no active underlying cardiac illnesses defined by positive stress test, LVEF <40% or ongoing life threatening arrhythmias.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414945


Contacts
Contact: Marcus Butler, M.D. 416-946-4521

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Marcus Butler, M.D.    416-946-4501 ext 5485    marcus.butler@uhn.ca   
Principal Investigator: Marcus Butler, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Marcus Butler, M.D. Princess Margaret Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02414945     History of Changes
Other Study ID Numbers: TILs-003-Meso
First Posted: April 13, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Interleukin-2
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents