Clinical trial · Interventional
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post-solid Organ Transplant | — | UNRESOLVED | — |
| Skin Neoplasms | Skin Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Difluoromethylornithine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
- timeFrame
- for 12 months
Secondary outcomes (2)
- measure
- To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%
- timeFrame
- for the 12 months of therapy
- measure
- To determine if DFMO will be able to decrease polyamine levels in skin biopsies
- timeFrame
- for the 12 months of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * \>1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney * Adequate organ function * Hearing age/gender appropriate * At high risk for developing skin cancer * Immunosuppressant levels and doses show stable graft function Exclusion Criteria: * Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA) * Systemic therapy for cancer treatment or prophylaxis * Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs \[NSAIDs\] (other than cardioprotective doses of aspirin)
References
Publications (0)
Data not yet available