DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma
NCT06892678 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-05-14
Summary
The purpose of this study is to determine the feasibility of administering DL-alpha-difluoromethylornithine (DFMO) to patients with relapsed Ewing sarcoma and osteosarcoma who have completed all planned therapy and have no evidence of disease.
Conditions
- Osteosarcoma Recurrent
- Ewing's Tumor Recurrent
Interventions
- DRUG
-
DFMO
DFMO dose will be calculated based on the BSA measured within 14 days prior to the beginning of each cycle. Tablets may be swallowed whole, chewed, or crushed and mixed with soft food or liquid.
Sponsors & Collaborators
- collaborator OTHER
-
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Alice Lee, MD · Montefiore Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 39 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-07
- Primary Completion
- 2030-04-30
- Completion
- 2030-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
CP-461 in the Treatment of Patients With Advanced Melanoma
NCT00060710 ·Status: TERMINATED ·Phase: PHASE2
-
Observational Study in Localized Osteosarcoma
NCT04890067 ·Status: RECRUITING
-
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
NCT03620019 ·Status: COMPLETED ·Phase: PHASE2
-
A Pilot Study of Sequential ONCOS-102, an Engineered Oncolytic Adenovirus Expressing GMCSF, and Pembrolizumab in Patients With Advanced or Unresectable Melanoma Progressing After Programmed Cell Death Protein 1 (PD1) Blockade
NCT03003676 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma
NCT05823246 ·Status: UNKNOWN ·Phase: PHASE2
-
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
NCT00204789 ·Status: COMPLETED ·Phase: PHASE2
-
Assessment of Safety and Efficacy of OPM-101 Combined With Anti-PD-1 in Patients With Advanced Melanoma Showing Resistance to Anti-PD-1
NCT07040436 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma
NCT02235701 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma
NCT02719015 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
A Safety and MORAb-028 Dose Determination Study in Subjects With Metastatic Melanoma
NCT01212276 ·Status: TERMINATED ·Phase: PHASE1
-
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
NCT00911443 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I/II Study of Dasatinib and Dacarbazine
NCT00597038 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Neoadjuvant Treatment Associated With Maintenance Therapy by Anti-PD1 Immunotherapy in Patients With Resectable Head and Neck Mucosal Melanoma
NCT03313206 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Anti PD-1 Plus Postbiotic Versus Anti PD-1 Alone in Locally Advanced or Metastatic, Treatment naïve, Cutaneous Melanoma Study
NCT07050940 ·Status: RECRUITING ·Phase: NA
-
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
NCT03352947 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
NCT02039947 ·Status: COMPLETED ·Phase: PHASE2
-
Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab
NCT02935790 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
NCT03199846 ·Status: COMPLETED
-
Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes
NCT03551626 ·Status: COMPLETED ·Phase: PHASE3
-
Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma
NCT02410863 ·Status: TERMINATED ·Phase: PHASE2
-
PVSRIPO in Combination With Nivolumab in Melanoma
NCT04125719 ·Status: WITHDRAWN ·Phase: PHASE1
-
Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome
NCT04960618 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b
NCT02339324 ·Status: COMPLETED ·Phase: PHASE1
-
A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France
NCT04550247 ·Status: ACTIVE_NOT_RECRUITING
-
Masitinib in Non-Resectable or Metastatic Stage 3/4 Melanoma Carrying a Mutation in the Juxta Membrane Domain of c-Kit
NCT01280565 ·Status: TERMINATED ·Phase: PHASE3