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出境医 / 临床实验 / Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

Study Description
Brief Summary:
To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Locally Advanced Refractory/Recurrent Melanoma Metastatic Head and Neck Cancer Locally Advanced Refractory/Recurrent Head and Neck Cancer Biological: Autologous Tumor Infiltrating Lymphocytes Biological: High-Dose Interleukin 2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: melanoma Biological: Autologous Tumor Infiltrating Lymphocytes
Autologous TILs

Biological: High-Dose Interleukin 2
720,000 IU/kg every 8 hours for up to 15 doses

Experimental: head and neck cancer Biological: Autologous Tumor Infiltrating Lymphocytes
Autologous TILs

Biological: High-Dose Interleukin 2
720,000 IU/kg every 8 hours for up to 15 doses

Outcome Measures
Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. treatment related Adverse Events [ Time Frame: 2 months ]
  2. Overall Response Rate [ Time Frame: 2 months ]
  3. Progression Free Survival [ Time Frame: 2 months ]

Eligibility Criteria
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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:

  • Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
  • Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:

    1. Not candidates for known curative intent therapy.
    2. Progressed following at least one prior systemic therapy.
    3. Have advanced melanoma unresectable stage III or stage IV
    4. Have advanced head and neck recurrent or metastatic disease
  • Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
  • Life expectancy of greater than 3 months.
  • ECOG Performance Status of 0 or 1.
  • Adequate organ and marrow function
  • Seronegative for HIV antibody.
  • Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
  • More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
  • Patient has stable or progressing disease after at least one prior treatment.
  • Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy

Exclusion Criteria:

  • Currently using investigational agents.
  • Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
  • Patient is a female of child-bearing potential who is pregnant or breastfeeding
  • Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
  • Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
  • Patient has opportunistic infections.
  • Patient has a history of coronary revascularization or ischemic symptoms.
  • Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
Contacts and Locations

Contacts
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Contact: Gregory Daniels, MD, PhD 858-534-3804 gdaniels@ucsd.edu
Contact: Yael Cohen-Arazi ycohenarazi@ucsd.edu

Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
Gregory Daniels
Immunotherapy Foundation
Investigators
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Principal Investigator: Gregory Daniels, MD, PhD University of California, San Diego
Principal Investigator: Ezra Cohen, MD University of California, San Diego
Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE October 7, 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
Dose Limiting Toxicity [ Time Frame: 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • treatment related Adverse Events [ Time Frame: 2 months ]
  • Overall Response Rate [ Time Frame: 2 months ]
  • Progression Free Survival [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
Official Title  ICMJE Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
Brief Summary To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Melanoma
  • Locally Advanced Refractory/Recurrent Melanoma
  • Metastatic Head and Neck Cancer
  • Locally Advanced Refractory/Recurrent Head and Neck Cancer
Intervention  ICMJE
  • Biological: Autologous Tumor Infiltrating Lymphocytes
    Autologous TILs
  • Biological: High-Dose Interleukin 2
    720,000 IU/kg every 8 hours for up to 15 doses
Study Arms  ICMJE
  • Experimental: melanoma
    Interventions:
    • Biological: Autologous Tumor Infiltrating Lymphocytes
    • Biological: High-Dose Interleukin 2
  • Experimental: head and neck cancer
    Interventions:
    • Biological: Autologous Tumor Infiltrating Lymphocytes
    • Biological: High-Dose Interleukin 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
  • Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:

    1. Not candidates for known curative intent therapy.
    2. Progressed following at least one prior systemic therapy.
    3. Have advanced melanoma unresectable stage III or stage IV
    4. Have advanced head and neck recurrent or metastatic disease
  • Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
  • Life expectancy of greater than 3 months.
  • ECOG Performance Status of 0 or 1.
  • Adequate organ and marrow function
  • Seronegative for HIV antibody.
  • Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
  • More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
  • Patient has stable or progressing disease after at least one prior treatment.
  • Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy

Exclusion Criteria:

  • Currently using investigational agents.
  • Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
  • Patient is a female of child-bearing potential who is pregnant or breastfeeding
  • Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
  • Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
  • Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
  • Patient has opportunistic infections.
  • Patient has a history of coronary revascularization or ischemic symptoms.
  • Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gregory Daniels, MD, PhD 858-534-3804 gdaniels@ucsd.edu
Contact: Yael Cohen-Arazi ycohenarazi@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991741
Other Study ID Numbers  ICMJE 160710
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gregory Daniels, University of California, San Diego
Study Sponsor  ICMJE Gregory Daniels
Collaborators  ICMJE Immunotherapy Foundation
Investigators  ICMJE
Principal Investigator: Gregory Daniels, MD, PhD University of California, San Diego
Principal Investigator: Ezra Cohen, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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