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

Launched by KARI KENDRA · Oct 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with stage IV melanoma that has spread to the brain. The trial is testing a type of immune cell therapy called UD TGFbetai natural killer (NK) cells, combined with a chemotherapy drug called temozolomide. The goal is to see if this combination can safely shrink tumors and improve outcomes for patients. Researchers are particularly interested in understanding the safety of this treatment and the best doses to use.

To be eligible for the trial, participants must be at least 18 years old and have confirmed stage IV melanoma with brain metastases. They should not have received other cancer treatments in the past four weeks and must meet certain health criteria, such as having stable blood counts and kidney function. Participants can expect to receive the study treatment and will be closely monitored for any side effects and how well the treatment works. It's important to note that women who can become pregnant and men who can father children will need to use effective birth control during the trial to ensure safety.

Gender

ALL

Eligibility criteria

• 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