Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Giselle Sholler
Study ID
NCT04301843
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 31 Years
Healthy Volunteers
Not accepted

Interventions

  • Eflornithine — DRUG
    DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.

Study Details

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma.

Key Dates

Start date
Sep 25, 2020
Status verified
Jan 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2033

Study Design

Enrollment
131 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Eflornithine (DFMO)
    In this study subjects will receive six 21-day cycles of Etoposide and DFMO followed by an additional 630 days of DFMO alone. Etoposide will be given at 50 mg/m2/dose PO daily for the first 14 days of each 21 days until 6 cycles of etoposide are completed. DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.

Primary Outcome Measure

Number of participants with event free survival (EFS) during study [ Time Frame: 2 years plus 5 years follow up ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
University of Alabama/Children's of AlabamaBirminghamAlabama35201
Bridget Tate
[email protected]
Elizabeth Alva (PRINCIPAL_INVESTIGATOR)
Arkansas Children's HospitalLittle RockArkansas72202
Kevin Bielamowicz (PRINCIPAL_INVESTIGATOR)
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609
Group Contact
[email protected]
Jennifer Michlitsch (PRINCIPAL_INVESTIGATOR)
Rady Children's HospitalSan DiegoCalifornia92123
Sherri Brandsen
[email protected]
William Roberts (PRINCIPAL_INVESTIGATOR)
Connecticut Children's HospitalHartfordConnecticut06106
Adam Barselau
[email protected]
Michael Isakoff (PRINCIPAL_INVESTIGATOR)
Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Marie Frankos
[email protected]
Jamie Libes-Bander (PRINCIPAL_INVESTIGATOR)
St. Joseph's Children's HospitalTampaFlorida33614
Jennifer Manns, RN
[email protected]
Don Eslin (PRINCIPAL_INVESTIGATOR)
Augusta University HealthAugustaGeorgia30912
Kimberly Gray
[email protected]
Coleen McDonough (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Christopher Stamy
[email protected]
David Dickens (PRINCIPAL_INVESTIGATOR)
Norton Children's Research Institute/Affiliated with University of Louisville School of MedicineLouisvilleKentucky40201
Jennifer Miller
[email protected]
Michael Ferguson (PRINCIPAL_INVESTIGATOR)
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Mary Beth Readwin
[email protected]
David Hoogstra (PRINCIPAL_INVESTIGATOR)
Children's Hospital and Clinics of MinnesotaMinneapolisMinnesota55404
Pauline Mitby
[email protected]
Jawhar Rawwas (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108
Nicole Harvey
[email protected]
Kevin Ginn (PRINCIPAL_INVESTIGATOR)
Cardinal Glennon Children's HospitalSt LouisMissouri63104
William Ferguson (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Kellie Daniel
[email protected]
Derek Hanson (PRINCIPAL_INVESTIGATOR)
Levine Children's HospitalCharlotteNorth Carolina28204
Jotnyce Green
[email protected]
Thomas Russell (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Children'sClevelandOhio44195
Stacey Thompason
[email protected]
Stacey Zahler (PRINCIPAL_INVESTIGATOR)
Randall Children's HospitalPortlandOregon97227
Jason Glover (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Medical Center and Children's HospitalHersheyPennsylvania17033
Penn State Clinical Trials
[email protected]
Valerie Brown (PRINCIPAL_INVESTIGATOR)
Hasbro Children's HospitalProvidenceRhode Island02901
Christopher Bouressa
[email protected]
Bradley DeNardo (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Shanta Salzar, MD
[email protected]
Jaqueline Kraveka (PRINCIPAL_INVESTIGATOR)
Dell Children's Blood and Cancer CenterAustinTexas78723
Rhea Robinson, RN
[email protected]
Virginia Harrod (PRINCIPAL_INVESTIGATOR)
Children's Medical Center DallasDallasTexas75235
Tanya Watt (PRINCIPAL_INVESTIGATOR)
Children's Hospital of The King's DaughtersNorfolkVirginia23507
Sabrina Wigginton
[email protected]
Wilson File (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Nathan Schloemer (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
University of Alabama/Children's of Alabama· Birmingham, ALArkansas Children's Hospital· Little Rock, ARUCSF Benioff Children's Hospital Oakland· Oakland, CARady Children's Hospital· San Diego, CAConnecticut Children's Hospital· Hartford, CTArnold Palmer Hospital for Children· Orlando, FL

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