Locally Advanced Refractory/Recurrent Head and Neck Cancer, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Metastatic Melanoma
Conditions
Keywords
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
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.
Detailed 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. 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).
Interventions
Autologous TILs
BIOLOGICALHigh-Dose Interleukin 2
720,000 IU/kg every 8 hours for up to 15 doses
Sponsors
Immunotherapy Foundation
Gregory Daniels
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicity | 2 months | Dose Limiting Toxicity (DLT) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solid Tumor Solid tumor
Autologous Tumor Infiltrating Lymphocytes: Autologous TILs
High-Dose Interleukin 2: 720,000 IU/kg every 8 hours for up to 15 doses | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Solid Tumor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 3 |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 3 / 3 |
Outcome results
Primary
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT)
Time frame: 2 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Solid Tumor | Dose Limiting Toxicity | Blood and Lymphatic System Disorders | 1 Participants |
| Solid Tumor | Dose Limiting Toxicity | Immune System Disorders, Renal and Urinary Disorders | 1 Participants |
| Solid Tumor | Dose Limiting Toxicity | Infections and Infestations, Endocrine Disorders, Metabolism and Nutrition Disorders, Investigations | 1 Participants |