Actively Recruiting
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
Led by Udai Kammula · Updated on 2025-07-10
47
Participants Needed
1
Research Sites
502 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Measurable metastatic uveal melanoma
- Co-enrollment on companion protocol for cell harvest and preparation with available TIL cultures
- Up to 3 brain metastases less than 1 cm in diameter, asymptomatic, and stable if treated; surgically resected brain metastases also allowed
- Age between 18 and 75 years
- Able to understand and sign informed consent
- Clinical performance status of ECOG 0 or 1
- Life expectancy greater than three months
- Willingness to use birth control during and for four months after treatment
- HIV antibody negative
- Hepatitis B antigen negative and hepatitis C antibody negative or HCV RNA negative if antibody positive
- Negative pregnancy test for women of child-bearing potential
- Absolute neutrophil count greater than 1000/mm3 without filgrastim
- White blood cell count at least 3000/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 8.0 g/dl
- Serum ALT/AST less than or equal to 3.5 times upper limit of normal
- Serum creatinine less than or equal to 1.6 mg/dl
- Total bilirubin less than or equal to 2.0 mg/dl, or less than 3.0 mg/dl in Gilbert's Syndrome
- More than four weeks since prior systemic therapy with recovery of toxicities to manageable levels (except alopecia or vitiligo)
- Minor surgery allowed if toxicities recovered to grade 1 or less
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Any primary immunodeficiency, including Severe Combined Immunodeficiency Disease
- Current opportunistic infections
- Active systemic infections, coagulation disorders, or other major active illnesses
- History of major organ autoimmune disease
- Use of systemic steroid therapy
- History of severe immediate allergic reaction to study agents
- Active coronary or ischemic symptoms
- Left ventricular ejection fraction (LVEF) less than or equal to 45%, especially if over 65 years or with arrhythmias or ischemic heart disease history
- Forced expiratory volume (FEV1) less than or equal to 60% predicted with smoking history or respiratory symptoms
- Receiving other investigational agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
J
Josh Tobin, RN
CONTACT
A
Allyson Welsch, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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