7 recruiting, 4 completed, 2 active not recruiting, 1 suspended. 15 Phase 2, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Recruiting 7, Completed 4, Active not recruiting 2, Suspended 1, Terminated 1 |
| Phase 1 | 6 | Recruiting 3, Completed 1, Suspended 1, Terminated 1 |
Follow DFMO: new trials by email Literature Review of DFMO trials Research Report on DFMO
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas Biospecimen Collection, Eflornithine, Lumbar Puncture - Anaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3 | Phase 1 / Phase 2 | Recruiting | Mayo Clinic | 33 | 2026-06-23 | 2026-06-24 |
| Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma Eflornithine, Topotecan, Cyclophosphamide - Osteosarcoma, Ewing Sarcoma | Phase 2 | Recruiting | Milton S. Hershey Medical Center | 406 | 2026-06-05 | 2026-10-06 |
| Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors AMXT 1501 Dicaprate, DFMO, Fulvestrant - Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer | Phase 1 / Phase 2 | Recruiting | Aminex Therapeutics, Inc. | 92 | 2026-01-26 | 2026-10-22 |
| DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma DFMO - Osteosarcoma Recurrent, Ewing's Tumor Recurrent | Phase 1 / Phase 2 | Recruiting | Montefiore Medical Center | 15 | 2025-04-07 | 2026-05-14 |
| Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO) Pembrolizumab, Difluoromethylornithine - Non Small Cell Lung Cancer, Lung Cancer | Phase 1 / Phase 2 | Suspended | H. Lee Moffitt Cancer Center and Research Institute | 45 | 2024-08-07 | 2026-03-06 |
| Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer DFMO, testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue - Prostate Cancer | Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 50 | 2023-10-04 | 2026-01-14 |
| TArgeting Type 1 Diabetes Using POLyamines (TADPOL) DFMO, Placebo - Type 1 Diabetes | Phase 2 | Active not recruiting | Emily K. Sims | 74 | 2023-03-14 | 2026-08-21 |
| Oral AMXT 1501 Dicaprate in Combination With IV DFMO AMXT1501, DFMO - Cancer, Solid Tumor | Phase 1 / Phase 2 | Terminated | Aminex Therapeutics, Inc. | 15 | 2022-11-29 | 2024-12-24 |
| DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma Difluoromethylornithine - Medulloblastoma | Phase 2 | Recruiting | Giselle Sholler | 118 | 2021-03-29 | 2026-08-12 |
| Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma Eflornithine - Neuroblastoma | Phase 2 | Active not recruiting | Giselle Sholler | 131 | 2020-09-25 | 2026-09-03 |
| Pediatric Precision Laboratory Advanced Neuroblastoma Therapy Ceritinib, dasatinib, sorafenib - Neuroblastoma | Phase 2 | Recruiting | Giselle Sholler | 500 | 2015-09-01 | 2026-09-04 |
| Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission DFMO - Neuroblastoma | Phase 2 | Completed | Giselle Sholler | 140 | 2015-03-05 | 2024-08-06 |
| Study of Difluoromethylornithine (DFMO) in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma DFMO, Bortezomib - Neuroblastoma Recurrent | Phase 1 / Phase 2 | Completed | Giselle Sholler | 16 | 2014-06-06 | 2024-08-06 |
| Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer Aspirin, Eflornithine, Laboratory Biomarker Analysis - Adenomatous Polyp | Phase 2 | Completed | National Cancer Institute (NCI) | 107 | 2009-08-20 | 2019-09-04 |
| Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis Celecoxib, Placebo, eflornithine - Colorectal Cancer, Familial Adenomatous Polyposis | Phase 2 | Completed | National Cancer Institute (NCI) | 205 | 2001-12-13 | 2020-09-29 |
Neuroblastoma (3) · Breast Neoplasms (2) · Carcinoma, Non-Small-Cell Lung (2) · Colorectal Neoplasms (2) · Glioma (2) · Melanoma (2) · Adenomatous Polyposis Coli (1) · Adenomatous Polyps (1) · Astrocytoma (1) · Diabetes Mellitus, Type 1 (1) · Diffuse Intrinsic Pontine Glioma (1) · Endometrial Neoplasms (1) · Esophageal Neoplasms (1) · Glioblastoma (1) · Head and Neck Neoplasms (1)
Giselle Sholler (5) · Aminex Therapeutics, Inc. (2) · National Cancer Institute (NCI) (2) · Emily K. Sims (1) · H. Lee Moffitt Cancer Center and Research Institute (1) · Mayo Clinic (1) · Milton S. Hershey Medical Center (1) · Montefiore Medical Center (1) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (1)
United States (15) · Canada (3) · Australia (1)
Giselle Sholler, MD (2) · Alice Lee, MD (1) · Deyaa Adib, MD (1) · Emily K Sims, MD,MS (1) · Frank A Sinicrope (1) · Giselle Saulnier-Sholler, MD (1) · Giselle SaulnierSholler, MD (1) · Jhanelle E. Gray, M.D. (1) · Kathleen Neville, MD (1) · Laura Sena, MD, PhD (1) · Michael A Huang, MD (1) · Michael Armstrong, MD (1) · Patrick Lynch (1) · Sue Lee, MD (1) · Terence C. Burns, MD, PhD (1)
PMID 32391579, PMID 10024506, PMID 10433086, PMID 10605821, PMID 10852253, PMID 11208527, PMID 11564949, PMID 11815483, PMID 12972423, PMID 15972654, PMID 16011702, PMID 16714282, PMID 17214730, PMID 1730582, PMID 17524725, PMID 18176934, PMID 18360702, PMID 19188144, PMID 19763038, PMID 19968980, PMID 19997760, PMID 20127992, PMID 20405312, PMID 20501948, PMID 20956533, PMID 21147316, PMID 21389784, PMID 22442300, PMID 23250488, PMID 25792707, PMID 26397425, PMID 2891995, PMID 3093066, PMID 3105526, PMID 3128541, PMID 32506485, PMID 34214479, PMID 34522028, PMID 37883734, PMID 38917371, PMID 431333, PMID 6422008, PMID 6781187, PMID 7895500, PMID 8262968, PMID 8295175, PMID 8356088, PMID 8408643, PMID 9719479
P30CA015083 (1), P30CA016672 (1), R01CA113681 (1)