Clinical Trials /

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

NCT03991741

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).

Related Conditions:
  • Cutaneous Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
  • Mucosal Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
Autologous Tumor Infiltrating Lymphocytesmelanoma
High-Dose Interleukin 2melanoma

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

NameTypeDescriptionInterventions
melanomaExperimental
  • Autologous Tumor Infiltrating Lymphocytes
  • High-Dose Interleukin 2
head and neck cancerExperimental
  • 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:Not yet 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

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