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N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

NCT02030964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-17

No results posted yet for this study

Summary

This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan.

* To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects.
* To find out the side effects seen by giving DFMO at different dose levels with celecoxib, cyclophosphamide and topotecan.
* To measure the levels of DFMO in the blood at different dose levels.
* To determine if your tumor gets smaller after treatment with DFMO, celecoxib, cyclophosphamide and topotecan.
* To determine if specific gene changes in you or your tumor makes you more prone to side effects or affects your tumor's response to the combination of DFMO, celecoxib, cyclophosphamide and topotecan.
* To determine if the amount of normal chemicals in your body called polyamines go down in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more likely to have a good response to the treatment if they do.

Conditions

Interventions

DRUG

DFMO

DRUG

Celecoxib

DRUG

Cyclophosphamide

DRUG

Topotecan

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • New Approaches to Neuroblastoma Therapy Consortium

    lead OTHER

Principal Investigators

  • Michael Hogarty, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-16
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02030964 on ClinicalTrials.gov