Impact of Valproate on Angiogenesis and Histone Deacetylation in Bladder Cancer

NCT01738815 | Completed Early Phase 1 DMC

• 1 other identifier: 256549
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematuria; Bladder Cancer

Keywords

bladder cancer; hematuria; sodium valproate; valproic acid

Outcome Measures

Primary Outcomes (1)

• Thrombospondin-1 gene expression

  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.

  1 day

Secondary Outcomes (1)

• Angiogenesis, proliferation, and histone deacetylase activity markers

  1 day

Study Arms (1)

valproic acid

EXPERIMENTAL

Patients will be administered valproic acid (Depakote ER) for up to 30 days prior to tumor resection

Drug: Valproic Acid

Interventions

Valproic Acid DRUG

500 mg orally, once daily for up to 30 days

Also known as: Depakote ER

valproic acid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over the age of 21
• Bladder tumor suspected or confirmed
• ECOG status 0 to 2
• 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

You may not qualify if:

• Allergy to valproic acid
• Concurrent chemotherapy
• Pre-menopausal women
• Active systemic infection (HepatitisB,C)
• Coagulation disorders
• Concurrent medication: Tolbutamide, Warfarin, Zidovudine, Benzodiazepine, Clonazepam, Diazepam, Any anti-convulsant therapy
• Seizure disorder
• Dementia
• History of Pancreatitis
• HIV diagnosis/treatment
• Liver disease/dysfunction

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Hematuria; Urinary Bladder Neoplasms

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Oleg Shapiro, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

US (1)