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

Conditions

• Locally Advanced Gastrointestinal Stromal Tumor
• Metastatic Gastrointestinal Stromal Tumor
• Recurrent Gastrointestinal Stromal Tumor
• Refractory Malignant Gastrointestinal Stromal Tumor
• Unresectable Malignant Gastrointestinal Stromal Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Aldesleukin — BIOLOGICAL
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo urine and blood sample collection
• Chest Radiography — PROCEDURE
  Undergo chest x-ray
• Computed Tomography — PROCEDURE
  Undergo CT
• Cyclophosphamide — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo echocardiography
• Filgrastim — BIOLOGICAL
  Given SC
• Fludarabine — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Surgical Procedure — PROCEDURE
  Undergo a second surgery
• Tumor Infiltrating Lymphocyte Therapy — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Aug 15, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

59 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (TIL, aldesleukin)
  Patients receive cyclophosphamide IV over 2 hours on days -8 and -7, fludarabine IV over 30 minutes on days -6 to -2 and TIL IV over 20-30 minutes on day 0 in the absence of disease progression or unacceptable toxicity. Starting within 24 hours of TIL infusion, patients receive aldesleukin IV over 15 minutes every 8 hours for up to 6 doses on days 0-3 in the absence of disease progression or unacceptable toxicity. Starting on day 1 or day 2, patients may receive filgrastim SC until neutrophil count \> 1 x 10\^9/L for 3 consecutive days or \> 5 x 10\^9/L. Patients with stable disease, partial response or recurrence may receive a second course of treatment. Patients also undergo chest x-ray at screening and urine and blood sample collection, CT, MRI or PET throughout the study. Additionally, patients may also undergo echocardiography or MUGA at screening and may also undergo a second surgery to collect cells on study.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 24 months ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  1-800-293-5066
  [email protected]

Locations (1)

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