TERMINATED

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

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Conditions

Metastatic MelanomaLocally Advanced Refractory/Recurrent MelanomaMetastatic Head and Neck CancerLocally Advanced Refractory/Recurrent Head and Neck Cancermelanomametastatichead and neck cancersolid tumoradoptive cell therapyautologousIL-2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-10-07
Study Completion:2023-01-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT03991741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
  2. * Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:
  3. 1. Not candidates for known curative intent therapy.
  4. 2. Progressed following at least one prior systemic therapy.
  5. 3. Have advanced melanoma unresectable stage III or stage IV
  6. 4. Have advanced head and neck recurrent or metastatic disease
  7. * 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.
  8. * Life expectancy of greater than 3 months.
  9. * ECOG Performance Status of 0 or 1.
  10. * Adequate organ and marrow function
  11. * Seronegative for HIV antibody.
  12. * Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
  13. * More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
  14. * Patient has stable or progressing disease after at least one prior treatment.
  15. * Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy
  1. * Currently using investigational agents.
  2. * Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
  3. * Patient is a female of child-bearing potential who is pregnant or breastfeeding
  4. * Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
  5. * 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.
  6. * Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
  7. * Patient has opportunistic infections.
  8. * Patient has a history of coronary revascularization or ischemic symptoms.
  9. * 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

Principal Investigator

Gregory Daniels, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego
Ezra Cohen, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: Gregory Daniels

  • Gregory Daniels, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego
  • Ezra Cohen, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-07
Study Completion Date2023-01-26

Study Record Updates

Study Start Date2020-10-07
Study Completion Date2023-01-26

Terms related to this study

Keywords Provided by Researchers

  • 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

  • Metastatic Melanoma
  • Locally Advanced Refractory/Recurrent Melanoma
  • Metastatic Head and Neck Cancer
  • Locally Advanced Refractory/Recurrent Head and Neck Cancer