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ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:24 AM EDT

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Showing 1–24 of 39 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Difluoromethylornithine Clear all
Completed Phase 1 Interventional

DFMO in Children With Type 1 Diabetes

NCT02384889
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Difluoromethylornithine, Placebo
Drug
Lead sponsor
Indiana University
Other
Eligibility
12 Years to 40 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
3
States / cities
Indianapolis, Indiana • Buffalo, New York • Wauwatosa, Wisconsin
Source: ClinicalTrials.gov public record
Updated Sep 5, 2021 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Results available

Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

NCT00033371
View directory record Official record
Conditions
Colorectal Cancer, Familial Adenomatous Polyposis
Interventions
Celecoxib, Placebo, eflornithine, Laboratory biomarker analysis, Questionnaire administration
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 65 Years
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2009
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 29, 2020 · Synced Oct 17, 2026, 8:24 AM EDT
Recruiting Phase 2 Interventional

Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

NCT07321912
View directory record Official record
Conditions
Osteosarcoma, Ewing Sarcoma
Interventions
Eflornithine, Topotecan, Cyclophosphamide, Vincristine, Doxorubicin, Ifosfamide, Etoposide, Cisplatin, Methotrexate
Drug
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
0 Years to 50 Years
Enrollment
406 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2036
U.S. locations
3
States / cities
Tampa, Florida • Portland, Oregon • Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 6, 2026 · Synced Oct 17, 2026, 8:24 AM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers

Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial

NCT04403282
View directory record Official record
Conditions
Pseudofolliculitis Barbae
Interventions
Eflornithine Topical, Placebo Eflornithine Topical
Drug
Lead sponsor
Walter Reed National Military Medical Center
Federal
Eligibility
18 Years to 64 Years
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jan 31, 2024 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Results available

Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin

NCT00601640
View directory record Official record
Conditions
Other Benign Neoplasm of Skin, Unspecified
Interventions
Diclofenac Na gel, Eflornithine HCL ointment
Drug
Lead sponsor
University of Arizona
Other
Eligibility
40 Years and older
Enrollment
184 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
3
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated Mar 23, 2017 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional

Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy

NCT00086736
View directory record Official record
Conditions
Prostate Cancer
Interventions
bicalutamide, eflornithine, oral eflornithine placebo, oral bicalutamide placebo
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older · Male only
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2003
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Nov 19, 2013 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Results available

Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer

NCT00983580
View directory record Official record
Conditions
Adenomatous Polyp
Interventions
Aspirin, Eflornithine, Laboratory Biomarker Analysis, Placebo, Telephone-Based Intervention
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
40 Years and older
Enrollment
107 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2019
U.S. locations
3
States / cities
Chicago, Illinois • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Sep 4, 2019 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 1 Interventional Results available

Safety Study for Refractory or Relapsed Neuroblastoma With DFMO Alone and in Combination With Etoposide

NCT01059071
View directory record Official record
Conditions
Neuroblastoma
Interventions
DFMO, Etoposide
Drug
Lead sponsor
Giselle Sholler
Other
Eligibility
Not listed
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2015
U.S. locations
7
States / cities
Orange, California • Hartford, Connecticut • Orlando, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2024 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 3 Interventional Results available

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

NCT01483144
View directory record Official record
Conditions
Familial Adenomatous Polyposis
Interventions
Eflornithine, Eflornithine Placebo, Sulindac 150 MG, Sulindac placebo
Drug
Lead sponsor
Cancer Prevention Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
171 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2019
U.S. locations
10
States / cities
La Jolla, California • Atlanta, Georgia • Boston, Massachusetts + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional

Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

NCT00021294
View directory record Official record
Conditions
Non-melanomatous Skin Cancer, Precancerous/Nonmalignant Condition
Interventions
eflornithine, triamcinolone
Drug
Lead sponsor
University of Arizona
Other
Eligibility
18 Years to 120 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2002
U.S. locations
1
States / cities
Tucson, Arizona
Source: ClinicalTrials.gov public record
Updated Sep 11, 2018 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Results available

Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission

NCT02395666
View directory record Official record
Conditions
Neuroblastoma
Interventions
DFMO
Drug
Lead sponsor
Giselle Sholler
Other
Eligibility
Up to 21 Years
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
22
States / cities
Phoenix, Arizona • Little Rock, Arkansas • San Diego, California + 19 more
Source: ClinicalTrials.gov public record
Updated Aug 6, 2024 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer

NCT04091022
View directory record Official record
Conditions
Non-melanoma Skin Cancer
Interventions
Solaraze and Vaniqa
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
2
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Dec 17, 2025 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Results available

Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

NCT00006101
View directory record Official record
Conditions
Prostate Cancer
Interventions
eflornithine, Placebo
Drug
Lead sponsor
Thomas E. Ahlering
Other
Eligibility
35 Years to 70 Years · Male only
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2012
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated May 14, 2018 · Synced Oct 17, 2026, 8:24 AM EDT
Active, not recruiting Phase 2 Interventional

Neuroblastoma Maintenance Therapy Trial

NCT02679144
View directory record Official record
Conditions
Neuroblastoma
Interventions
Difluoromethylornithine (DFMO)
Drug
Lead sponsor
Giselle Sholler
Other
Eligibility
1 Year to 30 Years
Enrollment
441 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2033
U.S. locations
41
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Oakland, California + 38 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers

Effect of 15% Eflornithine Hydrochloride Cream on African-American Males With Pseudofolliculitis Barbae

NCT00176995
View directory record Official record
Conditions
Pseudofolliculitis Barbae
Interventions
15% Eflornithine Hdyrochloride
Drug
Lead sponsor
Hordinsky, Maria K., MD
Individual
Eligibility
18 Years and older · Male only
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
1999 – 2000
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 13, 2006 · Synced Oct 17, 2026, 8:24 AM EDT
Recruiting Early Phase 1 Interventional

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

NCT05717153
View directory record Official record
Conditions
Diffuse Glioma, Malignant Glioma
Interventions
Biospecimen Collection, Computed Tomography, Eflornithine, Magnetic Resonance Imaging, Polyamine Transport Inhibitor AMXT-1501 Dicaprate, Resection, Microdialysis, Placement
Procedure · Drug · Device
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 4, 2025 · Synced Oct 17, 2026, 8:24 AM EDT
Active, not recruiting Phase 2 Interventional

TArgeting Type 1 Diabetes Using POLyamines (TADPOL)

NCT05594563
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
DFMO, Placebo
Drug
Lead sponsor
Emily K. Sims
Other
Eligibility
4 Years to 40 Years
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
7
States / cities
Aurora, Colorado • Chicago, Illinois • Indianapolis, Indiana + 4 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2026 · Synced Oct 17, 2026, 8:24 AM EDT
Recruiting Phase 1Phase 2 Interventional

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma

NCT06892678
View directory record Official record
Conditions
Osteosarcoma Recurrent, Ewing's Tumor Recurrent
Interventions
DFMO
Drug
Lead sponsor
Montefiore Medical Center
Other
Eligibility
Up to 39 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Oct 17, 2026, 8:24 AM EDT
Not listed Phase 3 Interventional

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

NCT02796261
View directory record Official record
Conditions
Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma
Interventions
Eflornithine, Lomustine
Drug
Lead sponsor
Orbus Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
343 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2023
U.S. locations
47
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 37 more
Source: ClinicalTrials.gov public record
Updated Jan 21, 2022 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 1 Interventional

Oral AMXT 1501 Dicaprate in Combination With DFMO

NCT03536728
View directory record Official record
Conditions
Cancer, Solid Tumor, Solid Carcinoma, Advanced Cancer
Interventions
AMXT1501, DFMO
Drug
Lead sponsor
Aminex Therapeutics, Inc.
Industry
Eligibility
12 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
4
States / cities
Austin, Texas • Houston, Texas • San Antonio, Texas + 1 more
Source: ClinicalTrials.gov public record
Updated May 25, 2023 · Synced Oct 17, 2026, 8:24 AM EDT
Recruiting Phase 2 Interventional

Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

NCT02559778
View directory record Official record
Conditions
Neuroblastoma
Interventions
Ceritinib, dasatinib, sorafenib, vorinostat, DFMO
Drug
Lead sponsor
Giselle Sholler
Other
Eligibility
Up to 22 Years
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2035
U.S. locations
24
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Oakland, California + 21 more
Source: ClinicalTrials.gov public record
Updated Sep 4, 2026 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 1 Interventional

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

NCT02030964
View directory record Official record
Conditions
Neuroblastoma
Interventions
DFMO, Celecoxib, Cyclophosphamide, Topotecan
Drug
Lead sponsor
New Approaches to Neuroblastoma Therapy Consortium
Other
Eligibility
2 Years to 30 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2023
U.S. locations
11
States / cities
Los Angeles, California • San Francisco, California • Aurora, Colorado + 8 more
Source: ClinicalTrials.gov public record
Updated Feb 17, 2025 · Synced Oct 17, 2026, 8:24 AM EDT
Completed Phase 2 Interventional

Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

NCT00006079
View directory record Official record
Conditions
Cervical Cancer, Precancerous Condition
Interventions
Eflornithine, Placebo
Drug · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2004
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Oct 25, 2018 · Synced Oct 17, 2026, 8:24 AM EDT
Recruiting Phase 2 Interventional

DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma

NCT04696029
View directory record Official record
Conditions
Medulloblastoma
Interventions
Difluoromethylornithine
Drug
Lead sponsor
Giselle Sholler
Other
Eligibility
Up to 21 Years
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
25
States / cities
Little Rock, Arkansas • Oakland, California • Sacramento, California + 22 more
Source: ClinicalTrials.gov public record
Updated Aug 12, 2026 · Synced Oct 17, 2026, 8:24 AM EDT