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
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.
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.
Eligibility
Minimum age: 2 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
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
hypersensitivity).
- Patients with known hypersensitivity to celecoxib or other NSAIDs, aspirin or
sulfonamides.
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
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