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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of universal donor TGFbetai natural killer (NK) cells combined with temozolomide in patients with stage IV melanoma that has spread to the brain. The study is divided into two phases: the first phase focuses on determining the safety and optimal dosage of the NK cells, while the second phase assesses the response rates and overall survival of participants. Patients will receive NK cell therapy followed by temozolomide, with various outcomes being measured, including intracranial and extracranial response rates. The trial aims to enhance anti-tumor immunity and improve treatment outcomes for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Kari L Kendra, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.