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

Study Overview
=================
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).

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

Conditions
-----------------
Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer

Intervention / Treatment
-----------------
* Biological: Autologous Tumor Infiltrating Lymphocytes
* Biological: High-Dose Interleukin 2


Participation Criteria
=================
Eligibility 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: Not candidates for known curative intent therapy. Progressed following at least one prior systemic therapy. Have advanced melanoma unresectable stage III or stage IV 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: melanoma<br> | Biological: Autologous Tumor Infiltrating Lymphocytes<br>* Autologous TILs<br>Biological: High-Dose Interleukin 2<br>* 720,000 IU/kg every 8 hours for up to 15 doses<br>|
| Experimental: head and neck cancer<br> | Biological: Autologous Tumor Infiltrating Lymphocytes<br>* Autologous TILs<br>Biological: High-Dose Interleukin 2<br>* 720,000 IU/kg every 8 hours for up to 15 doses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicity |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment related Adverse Events |  | 2 months | 
| Overall Response Rate |  | 2 months | 
| Progression Free Survival |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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