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Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma

NCT02139397 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-06

Study results available
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Summary

The purpose of this research study is to evaluate an investigational drug (DFMO) in combination with bortezomib, for relapsed and refractory neuroblastoma. DFMO is an investigational drug because it has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the safety and tolerability of DFMO in combination with bortezomib as well as the tumors response to this study drug.

Conditions

  • Neuroblastoma Recurrent

Interventions

DRUG

DFMO

DRUG

Bortezomib

Sponsors & Collaborators

  • Beat NB Cancer Foundation

    collaborator OTHER

  • Because of Ezra

    collaborator OTHER

  • K C Pharmaceuticals Inc.

    collaborator INDUSTRY

  • Giselle Sholler

    lead OTHER

Principal Investigators

  • Kathleen Neville, MD · Children's Mercy Hospital Kansas City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-06
Primary Completion
2024-01-19
Completion
2024-01-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02139397 on ClinicalTrials.gov