Clinical trial · Interventional
S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease
NCT00087295CI-TRIAL-00008408terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Permanently Closed Due to Poor Accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.
Conditions
Conditions (3)
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 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Depsipeptide | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Depsipeptide
- interventionNames
- Drug: Depsipeptide
Primary outcomes (1)
- measure
- Probability of response (confirmed complete and partial)
- timeFrame
- From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed transitional cell carcinoma of the urothelium (bladder, renal pelvis, ureter, or urethra)
* Metastatic disease
* Node-positive, non-metastatic disease that is unresectable is allowed
* Poorly differentiated transitional cell carcinoma OR predominant transitional cell carcinoma with rare foci of squamous differentiation or rare foci of adenocarcinoma allowed
* The following histologic types are not allowed:
* Adenocarcinoma
* Small cell carcinoma
* Sarcoma
* Squamous cell carcinoma
* Mixed adeno/squamous/transitional histology
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
* Soft tissue disease irradiated within the past 2 months is not considered measurable
* Disease progression or recurrence after 1, and only 1, prior systemic chemotherapy regimen that included cisplatin or carboplatin for metastatic disease
* Not curable by surgery or radiotherapy
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* White blood cell (WBC) count ≥ 3,000/mm\^3
Hepatic
* Aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin normal
Renal
* Creatinine ≤ 2 times ULN
Cardiovascular
* Corrected QT interval (QTc) \< 500 msec
* Left ventricular ejection fraction (LVEF) \> 40% by Multi Gated Acquisition Scan (MUGA)
* No New York Heart Association class III or IV congestive heart failure
* No myocardial infarction within the past year
* No uncontrolled dysrhythmias
* No poorly controlled angina
* No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* No left ventricular hypertrophy on EKG
* No other significant cardiac disease
Other
* Potassium ≥ 4 mmol/L
* Magnesium ≥ 2 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior allergic reaction to compounds of similar chemical or biological composition to FR901228 (depsipeptide)
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent immunotherapy
Chemotherapy
* See Disease Characteristics
* At least 28 days since prior chemotherapy
* No prior FR901228 (depsipeptide)
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormonal therapy
Radiotherapy
* See Disease Characteristics
* More than 28 days since prior radiotherapy
* No concurrent radiotherapy
Surgery
* More than 28 days since prior surgery
Other
* Recovered from all prior therapy
* More than 28 days since prior intravesical therapy
* No concurrent hydrochlorothiazide
* No concurrent agent that causes QTc prolongation
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational histone deacetylase inhibitor agents or drugs (e.g., sodium valproate)
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.