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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Gregory Daniels
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gregory Daniels, MD, PhDEzra Cohen, MD
Principal Investigator Affiliation University of California, San DiegoUniversity of California, San Diego
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer
Arms & Interventions


Experimental: melanoma

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UC San Diego Moores Cancer Center, La Jolla, California




UC San Diego Moores Cancer Center

La Jolla, California, 92093

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