Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
Primary Purpose
Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Tumor Infiltrating Lymphocytes
High-Dose Interleukin 2
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring 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
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.
Sites / Locations
- UC San Diego Moores Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
melanoma
head and neck cancer
Arm Description
Outcomes
Primary Outcome Measures
Dose Limiting Toxicity
Secondary Outcome Measures
treatment related Adverse Events
Overall Response Rate
Progression Free Survival
Full Information
NCT ID
NCT03991741
First Posted
April 10, 2019
Last Updated
December 1, 2022
Sponsor
Gregory Daniels
Collaborators
Immunotherapy Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03991741
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregory Daniels
Collaborators
Immunotherapy Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
melanoma
Arm Type
Experimental
Arm Title
head and neck cancer
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Autologous Tumor Infiltrating Lymphocytes
Intervention Description
Autologous TILs
Intervention Type
Biological
Intervention Name(s)
High-Dose Interleukin 2
Intervention Description
720,000 IU/kg every 8 hours for up to 15 doses
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity
Time Frame
2 months
Secondary Outcome Measure Information:
Title
treatment related Adverse Events
Time Frame
2 months
Title
Overall Response Rate
Time Frame
2 months
Title
Progression Free Survival
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Daniels, MD, PhD
Phone
858-534-3804
Email
gdaniels@ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine O'neil
Email
croneil@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Daniels, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ezra Cohen, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
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