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

Information source: New Approaches to Neuroblastoma Therapy Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroblastoma

Intervention: DFMO (Drug); Celecoxib (Drug); Cyclophosphamide (Drug); Topotecan (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: New Approaches to Neuroblastoma Therapy Consortium

Overall contact:
Araz Marchelian, MD, Phone: 323-361-5867, Email: nantops@chla.usc.edu


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.

Clinical Details

Official title: N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan for Patients With Relapsed or Refractory Neuroblastoma

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with adverse events as a measure of safety and tolerability.


Minimum age: 2 Years. Maximum age: 30 Years. Gender(s): Both.


Inclusion Criteria:

- Patients must be > 2 years and < 30 years of age when registered on study.

- Patients must have recurrent/progressive high-risk neuroblastoma, refractory

high-risk neuroblastoma that had less than a partial response to standard treatment or persistent high-risk neuroblastoma that had at least a partial response to standard treatment.

- All patients must have at least ONE site of evaluable disease.

- Patients must have adequate heart, kidney, liver and bone marrow function.

- Patients who have bone marrow disease must still have adequate bone marrow function

to enter the study.

- Patients with other ongoing serious medical issues must be approved by the study

chair prior to registration. Exclusion Criteria:

- Females of childbearing potential that do not have a negative pregnancy test.

- Patients that are pregnant, breast feeding, or unwilling to use effective

contraception during the study

- Patients status post allogeneic stem cell transplant.

- Patients who, in the opinion of the investigator, may not be able to comply with the

safety monitoring requirements of the study.

- Patients with disease of any major organ system that would compromise their ability

to withstand therapy.

- Patients who are on hemodialysis.

- Patients with an active or uncontrolled infection. Patients on prolonged antifungal

therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.

- Patients with active bleeding of the GI tract or patients who have symptoms

associated with stomach irritation (known as gastritis).

- Patients who have had a seizure within 12 months prior to enrollment and patients

receiving anti-convulsant therapy for a seizure disorder.

- Patients with known Aspirin-Hypersensitivity triad (asthma, allergic rhinitis, ASA


- Patients with known hypersensitivity to celecoxib or other NSAIDs, aspirin or


Locations and Contacts

Araz Marchelian, MD, Phone: 323-361-5867, Email: nantops@chla.usc.edu

Sydney Childrens Hospital KCC, Randwick 2031, Australia; Recruiting
David Ziegler, MBBS, Phone: 61-2-9382-1730

Children's Hospital Los Angeles, Los Angeles, California 90027-0700, United States; Recruiting
Araz Marachelian, MD, Phone: 323-361-5687, Email: amarachelian@chla.usc.edu

Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto, California 94304, United States; Recruiting
Clare Twist, MD, Phone: 650-723-5535

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States; Recruiting
Katherine Matthay, MD, Phone: 415-476-3831, Email: matthayK@peds.ucsf.edu

Children Hospital of Colorado, Aurora, Colorado 80045, United States; Recruiting
Margaret Macy, MD, Phone: 720-777-8856, Email: Margaret.macy@childrenscolorado.org

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta, Georgia 30322, United States; Recruiting
Kelly Goldsmith, MD, Phone: 404-785-0853, Email: kgoldsm@emory.edu

University of Chicago Comer Children's Hospital, Chicago, Illinois 60637, United States; Recruiting
Susan L. Cohn, MD, Phone: 773-702-2571, Email: scohn@peds.bsd.uchicago.edu

Childrens Hospital Boston, Dana-Farber Cancer Institute., Boston, Massachusetts 02115, United States; Recruiting
Suzanne - Shusterman, MD, Phone: 617-632-3725, Email: suzanne_shusterman@dfci.harvard.edu

C.S Mott Children's Hospital, Ann Arbor, Michigan 48109, United States; Recruiting
Gregory Yanik, MD, Phone: 734-936-8785, Email: gyanik@umich.edu

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States; Recruiting
Brian Weiss, MD, Phone: 513-636-9863, Email: brian.weiss@chmcc.org

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Meredith Irwin, MD

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-4318, United States; Recruiting
Yael Mosse, MD, Phone: 215-590-0965, Email: mosse@chop.edu

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States; Recruiting
Meaghan Granger, MD, Phone: 682-885-4007, Email: Mgranger@cookchildrens.org

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States; Recruiting
Julie R. Park, MD, Phone: 206-987-1947, Email: Julie.park@seattlechildrens.org

Additional Information

Starting date: December 2013
Last updated: August 14, 2015

Page last updated: August 23, 2015

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