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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Natural Killer Cell Therapy — BIOLOGICAL
  Given UD TGFbi NK cell IV
• Temozolomide — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Mar 1, 2023

Status verified

Apr 2026

Primary completion

Apr 15, 2027

Completion

Apr 15, 2027

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (UD TGFbetai NK cells, temozolomide)
  Patients receive UD TGFbetai NK cells IV over 30 minutes on day 1 and temozolomide PO daily on days 1-5. Treatment with UD TGFbetai NK cells repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Cycles of temozolomide repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose limited toxicities (Phase I) [ Time Frame: Up to 28 days ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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