Clinical trial · Interventional
Impact of Valproate on Angiogenesis and Histone Deacetylation in Bladder Cancer
NCT01738815CI-TRIAL-00054617completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The goal of this study is to test whether the drug valproic acid can cause changes in bladder tumors that might inhibit their growth.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Hematuria | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valproic Acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- valproic acid
- description
- Patients will be administered valproic acid (Depakote ER) for up to 30 days prior to tumor resection
- interventionNames
- Drug: Valproic Acid
Primary outcomes (1)
- measure
- Thrombospondin-1 gene expression
- timeFrame
- 1 day
- description
- Expression of thrombospondin-1 will be assayed using quantitative real-time PCR and western blotting. Comparisons will be intra-patient for paired specimens acquired prior to and after treatment and inter-patient for treated and un-treated patients.
Secondary outcomes (1)
- measure
- Angiogenesis, proliferation, and histone deacetylase activity markers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient over the age of 21 2. Bladder tumor suspected or confirmed 3. ECOG status 0 to 2 4. Premedication Lab values: Absolute Neutrophil Count \>750 cells/m3 AST/ALT less than 1.5xN Amylase less than 1.5xN Platelet Count \> 125,000 PT/PTT \> 1.3xN Hemoglobin \> 8gm/dL Creatinine less than 1.5xN Exclusion Criteria: 1. Allergy to valproic acid 2. Concurrent chemotherapy 3. Pre-menopausal women 4. Active systemic infection (HepatitisB,C) 5. Coagulation disorders 6. Concurrent medication: Tolbutamide, Warfarin, Zidovudine, Benzodiazepine, Clonazepam, Diazepam, Any anti-convulsant therapy 7. Seizure disorder 8. Dementia 9. History of Pancreatitis 10. HIV diagnosis/treatment 11. Liver disease/dysfunction
References
Publications (0)
Data not yet available
No reference posted for this study.