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

Phase 1

Recruiting

• Conditions: Metastatic Head and Neck Cancer; Metastatic Melanoma; Locally Advanced Refractory/Recurrent Melanoma; Locally Advanced Refractory/Recurrent Head and Neck Cancer
• Interventions: Biological: Autologous Tumor Infiltrating Lymphocytes; Biological: High-Dose Interleukin 2

• Registration Number: NCT03991741
• Lead Sponsor: Gregory Daniels

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2020-10-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05
• Primary Completion: 2024-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
head and neck cancer	High-Dose Interleukin 2	-
head and neck cancer	Autologous Tumor Infiltrating Lymphocytes	-
melanoma	Autologous Tumor Infiltrating Lymphocytes	-
melanoma	High-Dose Interleukin 2	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	2 months

Secondary Outcome Measures

Name	Time	Method
treatment related Adverse Events	2 months
Progression Free Survival	2 months
Overall Response Rate	2 months

Trial Locations

Locations (1)

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States