Actively Recruiting
Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
Led by Kari Kendra · Updated on 2026-01-12
30
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I/II trial tests the safety, side effects, and best dose of universal donor UD TGFbetai natural killer (NK) cells, and whether UD TGFbetai NK cells with temozolomide works to shrink tumors in patients with stage IV melanoma that has spread to the brain (metastatic to the brain). NK cells are immune cells that contribute to anti-tumor immunity by recognizing and destroying transformed or stressed cells. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving UD TGFbetai NK cell and temozolomide may work better in treating patients with stage IV melanoma.
CONDITIONS
Official Title
Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage IV melanoma confirmed by tissue testing
- At least one measurable brain tumor lesion 10 mm or larger confirmed by MRI
- No need for stereotactic radiotherapy
- At least 4 weeks since any prior cancer treatment or radiation
- Absolute neutrophil count at least 1 x 10^9/L
- Platelet count above 100,000/L
- Hemoglobin level 10 g/dL or higher
- Creatinine level less than or equal to 1.5 times the upper normal limit
- Albumin level at least 2.5 g/dL
- Serum bilirubin less than 1.5 times the upper normal limit unless Gilbert's syndrome
- Liver enzymes AST and ALT below 5 times upper normal limit if liver metastases present or below 3 times without
- At least 18 years old
- ECOG performance status of 0 to 2 (able to perform daily activities)
- Women of childbearing potential must agree to use effective contraception during treatment and for 28 days after
- Men able to father a child must use contraception or abstain from sex during and 1 week after treatment
- Negative pregnancy test for women of childbearing potential before starting treatment
- Signed informed consent form
You will not qualify if you...
- Planned or concurrent cancer treatment or radiation therapy
- Use of corticosteroids for brain swelling above 4 mg daily without study investigator approval
- Contraindication to MRI scanning
- Other cancers unless in complete remission for at least 3 years and not needing treatment
- Severe or uncontrolled medical conditions like active infection or liver/kidney disease
- Pregnant or breastfeeding women
- Significant mental, psychological, social, or geographic issues preventing study participation or consent
- Use of other investigational drugs within 30 days before screening
- Leptomeningeal metastases seen on MRI
- Participation in another treatment study within 30 days
- Steroid doses above the lowest needed to control symptoms from brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
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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