Study on Eflornithine (DFMO) and Etoposide for Neuroblastoma That Has Returned or Not Responded to Treatment

Sponsor: Giselle Sholler

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04301843

Provider View

This clinical trial is testing a combination of two drugs, Eflornithine (DFMO) and Etoposide, to see if they can help treat neuroblastoma that has come back or hasn't responded to previous treatments.

Patient Parameters

Program Overview

The study is exploring the use of Eflornithine (DFMO) combined with Etoposide for patients with neuroblastoma that has returned or not responded to treatment. Participants will receive six cycles of both drugs over 21 days each, followed by DFMO alone for an additional 630 days. The study includes three groups: those with no active disease after additional therapy, those who have relapsed but currently show no active disease, and those with active disease.

Description

This study involves using two drugs, Eflornithine (DFMO) and Etoposide, to treat neuroblastoma that has either returned or not responded to previous treatments. Participants will receive six cycles of both drugs over 21 days each, followed by DFMO alone for an additional 630 days.

Participants will be divided into three groups:

  • Group 1: Patients with no active disease after receiving additional therapy for neuroblastoma that did not respond to standard treatments.
  • Group 2: Patients who have relapsed but currently show no active disease.
  • Group 3: Patients with active disease that has returned or not responded to treatment.

The study aims to evaluate the effectiveness of this drug combination in managing neuroblastoma.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with neuroblastoma and aged 30 years or younger, with a history of the disease returning or not responding to treatment.
  • Completed at least four cycles of aggressive chemotherapy.
  • Specific criteria for each group:
    • Groups 1 and 2: No active disease, confirmed by scans and tests.
    • Group 3: Active disease, confirmed by scans or tests.
  • Enrolled within 60 days of the last treatment.
  • Recovered from previous treatment side effects.
  • Meet specific timelines for recovery from previous treatments, such as chemotherapy, growth factors, and immunotherapy.
  • Have a performance status score of 60% or higher.
  • Life expectancy of more than 2 months.
  • Adequate organ function, confirmed by blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Provide written informed consent.

Exclusion Criteria

  • Body surface area less than 0.25 m2.
  • Previously received DFMO at a dose higher than 1000mg/m2 twice a day.
  • Previously received DFMO with Etoposide.
  • Currently taking another investigational drug or anticancer agents.
  • Have an uncontrolled infection.
  • Unable to comply with study requirements.

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