Clinical trial · Interventional
Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor. PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fenretinide | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fenretinide
- description
- Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.
- interventionNames
- Drug: Fenretinide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo orally every day for 12 months, taken 25 out of every 28 days.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Recurrence rate of transitional cell carcinoma (TCC)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2) transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria: * Newly diagnosed and no more than 4 weeks since resection * Secondary after being tumor free (including carcinoma in situ) for more than 12 months with no intravesical therapy within that 12 months OR * Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with Bacillus Calmette-Guerin (BCG). * Must have received 6 weeks of induction BCG followed by no evidence of disease by cystoscopy and cytology and then further treatment with 3 weekly doses of BCG. * Visible tumor totally resected within 4 weeks prior to study entry and no further surgery, intravesical therapy, or systemic therapy planned * No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection * No metastatic disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2 Life expectancy: * At least 2 years Hematopoietic: * white blood count (WBC) greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 11.0 g/dL Hepatic: * serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than 1.5 times upper limit of normal (ULN) Renal: * Creatinine less than 2.0 mg/dL Other: * Triglyceride level less than 2.5 times ULN * No other concurrent malignancy except nonmelanomatous skin cancer * No other malignancy within the past 5 years unless currently disease free, at least 6 months since prior therapy, no current or planned active therapy, and expected disease-free survival at least 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after the study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent systemic biologic therapy Chemotherapy: * See Disease Characteristics * No prior systemic cytotoxic chemotherapy for bladder cancer * At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer * No concurrent systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the bladder * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta carotene (at least 30 mg/day) * At least 3 months since prior retinoid therapy
References
Publications (1)
- RESULTSabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008 Jan 1;14(1):224-9. doi: 10.1158/1078-0432.CCR-07-0733. PMID 18172274