Clinical trial · Interventional
SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth
A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to poor accrual.
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth. PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- Fenretinide 200 mg PO days 1-25, q 28 days x 6 cycles.
- interventionNames
- Drug: fenretinide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven oral mucosal intraepithelial neoplasia Stage II: moderate dysplasia, keratosis with atypia Stage III: severe keratinizing or nonkeratinizing dysplasia No myelodysplastic syndrome No retinopathies PATIENT CHARACTERISTICS: See General Eligibility Criteria PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent endocrine therapy Radiotherapy: No concurrent radiotherapy Surgery: Prior surgical ablation of prior dysplastic sites allowed Other: At least 2 months since prior therapy toxicities Patient Characteristics-- Age: Not specified Performance Status: SWOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 1 month before, during, and at least 2 months after study
References
Publications (0)
Data not yet available