Clinical trial NCT03991741: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: 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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Immunotherapy Foundation
First posted: 2019-06-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 2 months
Secondary outcomes:
measure: treatment related Adverse Events
timeFrame: 2 months
measure: Overall Response Rate
timeFrame: 2 months
measure: Progression Free Survival
timeFrame: 2 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Gregory Daniels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Ezra Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: