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"Re-Stimulated" Tumor-Infiltrating Lymphocytes And Low-Dose Interleukin-2 Therapy in Patients With Melanoma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01883297
First received: June 11, 2013
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

This is a phase I clinical study for patients with metastatic 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) 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.


Condition Intervention Phase
Metastatic, Stage III or Stage IV, Melanoma
Biological: Re-stimulated tumor-infiltrating lymphocytes (TILs)
Biological: Interleukin-2
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Feasibility and Safety of Infusion of "Re-Stimulated" Autologous Tumor-Infiltrating Lymphocytes (TILs) Followed by Low-Dose Interleukin-2 Therapy in Metastatic Melanoma Patients

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Number occurrences and severity of side effects [ Time Frame: Starting at first dose of study treatment up to 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical response to treatment [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
  • Number of patients with an immunity and no immunity to the study treatment [ Time Frame: From start of the study up to 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 9
Study Start Date: June 2013
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Re-Stimulated Tumor-Infiltrating Lymphocytes and interleukin-2 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 3x10^7 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
Other Name: Aldesleukin, Proleukin, Recombinant Human Interleukin 2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Inclusion Criteria (Eligibility for Treatment):

  • Signed and dated the informed consent
  • Must have measurable, unresectable stage III or stage IV melanoma
  • No brain metastases or stable brain metastases for 3 months following definitive treatment.
  • Performance status of ECOG 0 or 1
  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883297

Locations
Canada, Ontario
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Marcus Butler, M.D.    416-946-4628    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
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01883297     History of Changes
Other Study ID Numbers: TILs-001-DC
Study First Received: June 11, 2013
Last Updated: June 18, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Measurable
Unresectable
Stage III
Stage IV
Metastatic
Melanoma
Tumor-Infiltrating Lymphocytes
Low-Dose Interleukin-2
Autologous dendritic cells
Anti-CD3 monoclonal antibody

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Interleukin-2
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Aldesleukin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014