Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03991741
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Immunotherapy Foundation
Information provided by (Responsible Party):
Gregory Daniels, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03991741


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

Locations
Layout table for location information
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
Gregory Daniels
Immunotherapy Foundation
Investigators
Layout table for investigator information
Principal Investigator: Gregory Daniels, MD, PhD University of California, San Diego
Principal Investigator: Ezra Cohen, MD University of California, San Diego
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gregory Daniels, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03991741    
Other Study ID Numbers: 160710
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregory Daniels, University of California, San Diego:
melanoma
metastatic
head and neck cancer
solid tumor
adoptive cell therapy
 autologous
locally advanced refractory/recurrent melanoma
locally advanced refractory/recurrent head and neck cancer
IL-2
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Neoplasms by Site
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs