Hydralazine as Demethylating Agent in Breast Cancer

NCT00575978 | Withdrawn Phase 1

• 1 other identifier: 2003-23
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted as a phase I/II clinical trial. In addition to determining the maximum tolerated dose (MTD) of hydralazine, the phase I trial will be performed to identify unexpected toxicities that may occur when hydralazine is used in conjunction with neoadjuvant chemotherapy in normotensive women with breast cancer. Once the phase I trial is successfully completed, the phase II trial to evaluate the efficacy of hydralazine in producing a demethylation effect will begin.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• To explore the potency of a clinical tolerable dose of hydralazine as a demethylating agent as indicated.

Secondary Outcomes (1)

• 1. Reversal of promoter methylation of eight Tumor Suppressor Genes (TSGs) reported as candidates for epigenetic silencing in breast cancer using Methylation-Specific

Study Arms (1)

Hydralazine

EXPERIMENTAL

The objective of this study is to determine the MTD for hydrazaline added to standard neoadjuvant chemotherapy for operable breast cancer. Four dose levels of hydrazalline are planned: Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID

Drug: Hydralazine

Interventions

Hydralazine DRUG

Dose Level 1: 150 mg/d 50 mg PO TID Dose Level 2: 200 mg/d 50 mg PO QID Dose Level 3: 225 mg/d 75 mg PO TID

Hydralazine

Eligibility Criteria

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

You may qualify if:

• Operable "invasive" breast cancer
• Signed informed consent
• Baseline blood pressure OFF antihypertensives \> 110/60 mmHg

You may not qualify if:

• Pre-existing hypotension
• Pre-existing liver disease (liver function tests \> 2x upper limits of normal ULM).
• Pre-existing kidney (serum creatinine \> 2 mg/dl).
• Medical necessity to remain on beta-blockers that cannot be met by other agents.

Sponsors & Collaborators

• University of Arkansas: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hydralazine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ahmed M Safar, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: June 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 4, 2015

Record last verified: 2015-03