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Autologous Tumor Infiltrating Lymphocytes With Interleukin-2 for the Treatment of Locally Advanced, Recurrent or Metastatic Gastrointestinal Stromal Tumors

ConditionsLocally Advanced Gastrointestinal Stromal TumorMetastatic Gastrointestinal Stromal TumorRecurrent Gastrointestinal Stromal TumorRefractory Malignant Gastrointestinal Stromal TumorUnresectable Malignant Gastrointestinal Stromal Tumor
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJoal Beane

About this trial

This phase II trial tests the effect of autologous tumor infiltrating lymphocytes (TILs) in combination with interleukin-2 (aldesleukin) in treating patients with gastrointestinal stromal tumors (GIST) that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Autologous TILs are made using the patient's own tumor cells collected from a previous surgery. Lymphocytes (a type of white blood cell) are a part of the immune system that helps the body fight infections. Lymphocytes are found in tumor tissue cells because they are working to attack the tumor. The cells from the tumor are grown in a lab to create more immune cells (lymphocytes). This may help the immune system find and destroy any remaining tumor cells. Aldesleukin is a form of interleukin-2, a cytokine made by leukocytes, that is made in the laboratory. Aldesleukin may help white blood cells and T cells regulate the immune response. Chemotherapy, such as cyclophosphamide and fludarabine, are given before receiving TIL to help kill tumor cells in the body and helps make room for the treatment. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Giving autologous TILs in combination with aldesleukin may be safe, tolerable, and/or effective in treating patients with locally advanced, recurrent or metastatic GIST.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Measurable locally advanced, recurrent, or metastatic GIST

Patients with locally advanced disease should be unresectable by conventional surgical approaches

Patients with distant metastatic spread must be refractory to approved standard systemic therapies (such as imatinib and sunitinib) if they are eligible to receive these treatments

Patients must be co-enrolled on the companion protocol Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies (institutional review board [IRB] #2024C0043), and have available TIL cultures for therapy

Disqualifiers

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant

Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)

Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities)

Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses

Trial design

Design model

Single group

Treatments tested in this trial

  • Aldesleukin

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo urine and blood sample collection

  • Chest Radiography

    Procedure/Surgery

    Undergo chest x-ray

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Cyclophosphamide

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Filgrastim

    Biological/Vaccine

    Given SC

  • Fludarabine

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Surgical Procedure

    Procedure/Surgery

    Undergo a second surgery

  • Tumor Infiltrating Lymphocyte Therapy

    Biological/Vaccine

    Given IV

Treatment groups

59 Participants
are divided into 1 treatment group
Group A: Treatment (TIL, aldesleukin)Experimental treatment 13 interventions

Trial outcomes

Primary outcomes

1

Objective response rate

Will be estimated by the proportion of patients with a best response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors criteria, with corresponding exact 95% confidence limit being reported.

Time frame
Up to 24 months

Secondary outcomes

1

CR rate

Will be estimated by the proportion of patients with a best response of complete response (CR) by Response Evaluation Criteria in Solid Tumors criteria

Time frame
Up to 24 months
2

Duration of response

The distribution among patients achieving CR or PR will be characterized by median and quartiles.

Time frame
Up to 24 months
3

Disease control rate

Time frame
Up to 24 months
4

Progression-free survival

Will be estimated by the Kaplan-Meier method. The corresponding median survival times (with 95% confidence limits) will be determined, as will the cumulative percentage of patients remaining progression-free (and the cumulative percentage-alive) at selected time points after initial treatment (e.g., 3, 6,12, 18 months).

Time frame
From the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), assessed up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joal Beane

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: