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New treatment option for Clinical Stage IV Cutaneous Melanoma AJCC v8
Official title Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
ClinicalTrials.gov ID: NCT05588453
What this study is testing
What is Natural Killer Cell Therapy?
Natural Killer Cell Therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clinical stage iv cutaneous melanoma ajcc v8.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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...
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
- Active infection
See the full eligibility 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.