Study on NK Cell Infusions with Irinotecan, Temozolomide, and Dinutuximab

Sponsor: Nationwide Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04211675

Provider View

This clinical trial is testing a new treatment that combines NK cell infusions with chemotherapy drugs irinotecan and temozolomide, and the immunotherapy drug dinutuximab, to see if it is safe and effective for young patients with certain types of cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for young patients with specific types of cancer, such as neuroblastoma. The treatment involves using NK cell infusions along with chemotherapy drugs irinotecan and temozolomide, and the immunotherapy drug dinutuximab. The first phase of the study will focus on the safety and tolerability of this combination, while the second phase will evaluate how well the treatment works in shrinking tumors.

Eligibility Criteria

Inclusion Criteria

  • Be under 30 years old.
  • Have a confirmed diagnosis of neuroblastoma or ganglioneuroblastoma, or neuroblastoma cells in the bone marrow.
  • Have a life expectancy of more than 2 months and meet one of the following conditions:
    • The cancer has returned after treatment.
    • The cancer has progressed during initial treatment.
    • The cancer did not respond well to initial treatment.
  • Have a measurable or evaluable tumor, as shown by specific scans or tests.
  • Have progressed during or after completing initial treatment, which may have included chemotherapy, radiation, stem cell transplant, or other therapies.
  • Have not received irinotecan or temozolomide in the last 6 months.
  • Have adequate bone marrow, kidney, liver, central nervous system, heart, and lung function, as determined by specific medical tests.

Exclusion Criteria

  • Be pregnant or breastfeeding.
  • Have only elevated catecholamines without other symptoms.
  • Have taken systemic steroids or certain medications affecting liver enzymes within 7 days before the study.
  • Have been diagnosed with another type of cancer.
  • Have severe diarrhea or an uncontrolled infection.
  • Have had severe allergic reactions to anti-GD2 antibodies.
  • Have any other significant illness that could interfere with the study treatment.

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