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).
Title
- Brief Title: Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
160710
- NCT ID:
NCT03991741
Conditions
- Metastatic Melanoma
- Locally Advanced Refractory/Recurrent Melanoma
- Metastatic Head and Neck Cancer
- Locally Advanced Refractory/Recurrent Head and Neck Cancer
Interventions
Drug | Synonyms | Arms |
---|
Autologous Tumor Infiltrating Lymphocytes | | head and neck cancer |
High-Dose Interleukin 2 | | head and neck cancer |
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).
Trial Arms
Name | Type | Description | Interventions |
---|
melanoma | Experimental | | - Autologous Tumor Infiltrating Lymphocytes
- High-Dose Interleukin 2
|
head and neck cancer | Experimental | | - Autologous Tumor Infiltrating Lymphocytes
- High-Dose Interleukin 2
|
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:
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Limiting Toxicity |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | treatment related Adverse Events |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Measure: | Overall Response Rate |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Measure: | Progression Free Survival |
Time Frame: | 2 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Gregory Daniels |
Trial 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
Last Updated
October 19, 2020