Back to search results

Natural Killer Cell Therapy and Temozolomide for Stage IV Melanoma with Brain Metastasis

This study is testing a new treatment for stage IV melanoma that has spread to the brain. It combines two treatments: UD TGFbetai natural killer (NK) cells and temozolomide. NK cells are immune cells that help fight cancer, and temozolomide is a chemotherapy drug that slows cancer growth. The study aims to find the safest dose and see how well this combination shrinks tumors in the brain. You might be able to join if you have stage IV melanoma with brain metastases (cancer spread to the brain) that can be measured and is getting worse, and if you are at least 18 years old. The researchers will measure how many people have their tumors shrink or disappear in the brain, and they will also track any side effects for up to 5 years. The study is currently unclear on its recruitment status and plans to enroll 24 participants.

Study design
This is a Phase I/II interventional study, meaning it tests safety and then effectiveness. It plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and tumor response for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05588453

Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kari Kendra
~24 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Natural Killer Cell TherapyTemozolomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limited toxicities (Phase I)
Measured over Up to 28 days
+2 more outcomes measured

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Malignant Neoplasm in the Brain
Metastatic Melanoma
Pathologic Stage IV Cutaneous Melanoma AJCC v8

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Kari L Kendra, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Histologically confirmed melanoma with stage IV disease
Radiologically confirmed brain metastasis (n \>= 1) with at least one measurable central nervous system (CNS) lesion \>= 10 mm on T1-weighted gadolinium enhanced magnetic resonance imaging (MRI) and unequivocal evidence of progression
No indication for stereotactic radiotherapy
At least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation)
Absolute neutrophil count (ANC) 1 x 10\^9/L
Platelets \> 100,000/L
Hemoglobin (Hgb) \>= 10 g/dL
Creatinine =\< 1.5 x upper limit of normal (ULN)
Albumin \>= 2.5 g/dL
Serum bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN if documented liver metastases or \< 3 X ULN without liver metastasis
\> 18 years old (y/o)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Females of reproductive age must agree to the use of an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 28 days after the final dose of investigational product for women. Males able to father a child must practice adequate methods of contraception or completely abstain from intercourse from the first dose of investigational treatment until one week after the final dose of investigational treatment
Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 48 hours prior to the administration of the first study treatment
Patient information and written informed consent form signed

Exclusion

Planned or concurrent systemic treatment or radiation therapy
If requiring corticosteroids for cerebral edema, patients must be on a stable dose. Lowest dose of steroids needed to control CNS edema is recommended. Doses above 4 mg daily need to be cleared by principal investigator (PI) of the study
Known contra-indication to MRI
Patients with non-melanoma malignancies are excluded unless a complete remission has been achieved at least 3 years prior to study entry and no additional therapy is required or anticipated during the study period (exceptions include: non-melanoma skin cancers, in situ bladder cancer, in situ gastric cancer, in situ colon cancers, in situ cervical cancers/dysplasia, or in situ breast carcinoma)
Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
Active infection
Current active hepatic or renal disease
Pregnant women, women who are likely to become pregnant or are breastfeeding
Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological, or geographical conditions potentially hampering ability to consent, compliance with the study protocol, and follow-up schedule; those conditions should be discussed with the patient before remigration in the trial
Patients who received any other investigational drugs within the 30 days prior to screening visit
Leptomeningeal metastases diagnosed by MRI
Inclusion in another therapeutic protocol within 30 days
If steroids are necessary to control symptoms related to CNS metastases, patients should be on the lowest dose of steroids necessary to control symptoms

What this trial measures

  • Dose limited toxicities (Phase I)Up to 28 days

    Toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 4.03. The CTCAE provides descriptive terminology and a grading scale for each adverse event listed. All toxicities will be summarized as the percentage of patients experiencing each type and grade of event according to dose level.

  • Incidence of adverse events (AEs) (Phase I)Up to 5 years

    Assessed using CTCAE version (V)4.0. All toxicities will be summarized as the percentage of patients experiencing each type and grade of event according to dose level. Patients who receive at least one dose of treatment will be included in the analysis. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

  • Proportion of subjects who achieve an intracranial complete response or partial response (Phase II)Up to 5 years

    Assessed using modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.