Study on Using NK Cell Infusions with Chemotherapy for Relapsed or Hard-to-Treat Pediatric Bone and Soft Tissue Cancers

Sponsor: Nationwide Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05634369

Provider View

This clinical trial is testing whether adding a type of immune cell infusion, called NK cells, to standard chemotherapy can improve outcomes for children and young adults with bone and soft tissue cancers that have returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if adding infusions of natural killer (NK) cells to the chemotherapy drugs gemcitabine and docetaxel can help treat childhood sarcomas that have come back or not responded to other treatments. The main goals are to see if this combination is safe and effective, and to check how long patients can go without the cancer getting worse. Participants will receive up to 8 cycles of treatment, each lasting 21 days, which includes chemotherapy and NK cell infusions.

Description

This study involves using a combination of chemotherapy and a special type of immune cell called NK cells to treat children and young adults with certain types of bone and soft tissue cancers that have returned or not responded to previous treatments. The treatment plan includes up to 8 cycles, each lasting 21 days, where patients receive chemotherapy drugs gemcitabine and docetaxel, along with NK cell infusions. The study will monitor the safety and effectiveness of this treatment approach, as well as any side effects that may occur. Participants will receive supportive medications to help manage side effects and improve their white blood cell counts. The study is conducted across multiple centers and includes regular safety and toxicity assessments to ensure the well-being of participants.

Eligibility Criteria

Inclusion Criteria

  • Age between 12 and 40 years old with relapsed or hard-to-treat bone or soft tissue cancers like osteosarcoma or Ewing sarcoma.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have had at least one but no more than four previous treatments for the cancer.
  • Must have normal organ and blood function as shown by specific tests.
  • Must not have received certain treatments recently, such as chemotherapy or radiation, within specified timeframes before starting the study.
  • Must be in good overall health with a performance status score of 60 or higher.
  • Women of childbearing potential must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Currently receiving other investigational treatments or medications for cancer.
  • Have a history of allergic reactions to the study drugs.
  • Have received prior cellular therapies like CAR-T cells.
  • Have cancer only in the bone marrow.
  • Have tumors near critical areas where swelling could cause problems.
  • Have cancer that has spread to the brain or central nervous system.
  • Taking medications that affect NK cell function, except for specific conditions.
  • Have uncontrolled illnesses or infections.
  • Pregnant or breastfeeding women cannot participate.
  • HIV-positive patients on antiretroviral therapy are not eligible.
  • Unable to comply with study requirements.

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