Impact of Valproate on Angiogenesis and Histone Deacetylation in Bladder Cancer

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to test whether the drug valproic acid can cause changes in bladder tumors that might inhibit their growth.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Treatments: Valproic Acid

Criteria

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