RecruitingPhase 2NCT03467516

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Uveal Melanoma


Sponsor

Udai Kammula

Enrollment

47 participants

Start Date

May 14, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 study in which the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with metastatic uveal melanoma will be evaluated. Metastatic uveal melanoma (UM) carries a poor prognosis with estimated survival of 4-6 months. There are no known effective systemic therapies. Metastatic UM is classified as an "orphan" disease and there are currently few clinical trial options for these patients. Thus, novel systemic approaches are desperately needed. A recent pilot study has found that administration of autologous tumor infiltrating lymphocytes (TIL) generated from resected metastases can induce objective tumor response and durable complete response in metastatic uveal melanoma patients. These encouraging results require confirmation to determine if this immunotherapy is of future benefit in treating this disease.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a treatment called TIL therapy (tumor-infiltrating lymphocyte therapy), where immune cells are taken from a patient's own melanoma tumor, grown in large numbers in the lab, and then infused back into the patient to help fight the cancer, in patients with uveal melanoma (a rare eye melanoma) that has spread. **You may be eligible if...** - You are between 18 and 75 years old - You have metastatic uveal melanoma (the cancer has spread from the eye to other organs) with measurable tumors - You are already enrolled in the companion cell preparation study at the same institution and have viable TIL cultures available - You are in good overall health (ECOG 0–1) - You have a life expectancy of more than 3 months - You have satisfactory blood counts, kidney, and liver function - You are negative for HIV, hepatitis B, and hepatitis C - You agree to use birth control during and for 4 months after treatment **You may NOT be eligible if...** - You have more than 3 brain metastases or brain tumors larger than 1 cm - You are HIV positive - You are pregnant - You have active hepatitis B or C - Your blood counts or organ function are below required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor Infiltrating Lymphocytes (TIL)

TIL infusion intravenously through a central vein catheter over 20-30 minutes. Folowed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of TIL infusion and continuing for up to a maximum of 6 doses.


Locations(1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

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NCT03467516


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