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Tumor-Infiltrating Lymphocytes And Low-Dose Interleukin-2 Therapy Following Cyclophosphamide And Fludarabine In Patients With Melanoma

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ClinicalTrials.gov Identifier: NCT01883323
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

This is a phase II clinical study for patients with metastatic (the cancer has spread to other parts of the body) melanoma. 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 which is an approved drug to treat melanoma. This study will see how useful this regimen is in treating metastatic melanoma.


Condition or disease Intervention/treatment Phase
Metastatic, Stage III or Stage IV, Melanoma Drug: Cyclophosphamide Drug: Fludarabine Biological: Tumor-Infiltrating Lymphocytes Biological: Low-Dose Interleukin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating The Infusion Of Autologous 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 Metastatic Melanoma
Study Start Date : June 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Cyclophosphamide and Fludarabine followed by TILs and IL-2
Cyclophosphamide, i.v., 60mg/kg per day for 2 days and Fludarabine, i.v., 25mg/m2 per day for 5 days; then Tumor-Infiltrating Lymphocytes, i.v., 1x10^10 - 1.6x10^11 cells and Low-Dose Interleukin, i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Drug: Cyclophosphamide
i.v., 60mg/kg per day for 2 days
Other Name: CYTOXAN, PROCYTOX

Drug: Fludarabine
i.v., 25mg/m2 per day for 5 days
Other Name: FLUDARA

Biological: Tumor-Infiltrating Lymphocytes
i.v., 1x10^10 - 1.6x10^11 cells

Biological: Low-Dose Interleukin
i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
Other Name: Aldesleukin, Proleukin, Recombinant Human Interleukin 2




Primary Outcome Measures :
  1. Clinical response to treatment [ Time Frame: 6 weeks after treatment ]

Secondary Outcome Measures :
  1. Number occurrences and severity of side effects [ Time Frame: Starting at first dose of study treatment up to 10 years ]
  2. Number of patients with an immunity and no immunity to the study treatment [ Time Frame: From start of study up to 10 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 (Eligibility for TIL Evaluation):

  • Must have measurable, unresectable stage III or stage IV melanoma
  • Suitable tumor for collection
  • If tumor is suitable for collection, patient must be suitable for surgery
  • Patient must be 18 years of age or older
  • Performance status of ECOG 0 or 1
  • Life expectancy > 5 months from date of consent of TIL evaluation
  • Willing to be tested for transmissible diseases
  • For patients with a history of allergy to penicillin, gentamycin, streptomycin, or anti-fungals, the ability to generate TILs will be confirmed with the cell manufacturing laboratory

Inclusion Criteria (Eligibility for Treatment):

  • Signed and dated the informed consent
  • No brain metastases or stable brain metastases for 3 months following definitive treatment.
  • Life expectancy > 3 months from the date of consent for TILs treatment
  • TILs are suitable for use as determined by laboratory
  • More than 30 days since any prior systemic therapy at the time of the cell infusion, or more than six weeks since prior nitrosurea therapy. For patients with prior ipilimumab therapy, at least six weeks must elapse between the last ipilimumab dose and the start of study treatment. All side effects from previous treatment must have recovered to an acceptable grade level.
  • Adequate organ function
  • Must have positive EBV titres
  • 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.

Exclusion Criteria:

  • Requiring systemic steroid therapy
  • HIV positive
  • With active hepatitis B or hepatitis C, syphilis, or HTLV
  • 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 following study procedures.
  • Have no active underlying cardiac illnesses defined by positive stress test, LVEF<40% or ongoing life-threatening arrhythmias
  • Abnormal lung function test

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): NCT01883323


Locations
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Butler Marcus, M.D. Princess Margaret Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01883323     History of Changes
Other Study ID Numbers: TILs-002-MEL
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Keywords provided by University Health Network, Toronto:
Measurable
Unresectable
Stage III
Stage IV
Metastatic
Melanoma
Tumor-Infiltrating Lymphocytes
Low-Dose Interleukin-2
Cyclophosphamide
Fludarabine

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Aldesleukin
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