Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|
- - 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.
- IV. 4.
- - Have no more than 3 brain metastases.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, 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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
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|
Experimental: head and neck cancer
Biological: - Autologous Tumor Infiltrating Lymphocytes
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.