Study on Natural Killer Cell Therapy and Temozolomide for Treating Stage IV Melanoma That Has Spread to the Brain

Sponsor: Kari Kendra

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05588453

Provider View

This clinical trial is testing a new treatment using natural killer cells and the drug temozolomide to see if it can safely and effectively shrink tumors in patients with stage IV melanoma that has spread to the brain.

Patient Parameters

Program Overview

This study is exploring a new treatment for stage IV melanoma that has spread to the brain. It involves using special immune cells called natural killer (NK) cells, along with a medication called temozolomide. NK cells help the body fight cancer by targeting and destroying cancer cells. Temozolomide is a drug that slows or stops the growth of cancer cells. The study aims to find the safest and most effective dose of this combination and to see if it can help reduce tumors in the brain.

Description

The study is divided into two phases. In Phase I, researchers will test the safety and best dose of the natural killer cells combined with temozolomide. In Phase II, they will evaluate how well this treatment works in shrinking brain tumors.

Participants will receive the natural killer cells through an IV on the first day of each treatment cycle, and take temozolomide pills daily for the first five days of each cycle. Each cycle lasts 28 days, and the treatment can be repeated for up to three cycles if the cancer does not progress and side effects are manageable.

After completing the treatment, participants will have follow-up visits every six months for up to five years to monitor their health and the long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV melanoma that has spread to the brain.
  • Have at least one brain tumor that is 10 mm or larger, confirmed by MRI.
  • No need for immediate stereotactic radiotherapy.
  • At least four weeks since any previous cancer treatments.
  • Meet specific blood count and organ function requirements.
  • Aged 18 years or older.
  • In good general health, with an ECOG performance status of 0 to 2.
  • Women of childbearing age must use effective birth control during and after treatment.
  • Men must use birth control or abstain from sex during and after treatment.
  • Women must have a negative pregnancy test before starting treatment.
  • Willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • Planning or currently receiving other cancer treatments or radiation.
  • Need for high doses of steroids for brain swelling.
  • Unable to undergo MRI scans.
  • Have other cancers unless in complete remission for at least three years.
  • Have severe or uncontrolled medical conditions that could affect participation.
  • Pregnant, planning to become pregnant, or breastfeeding.
  • Have mental or social conditions that could affect understanding or following the study.
  • Participated in another clinical trial within the last 30 days.
  • Have cancer spread to the membranes around the brain or spinal cord.

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