Hydralazine as Demethylating Agent in Breast Cancer

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Hydralazine

Criteria

Inclusion Criteria:

• Patients referred to the breast cancer service for diagnostic evaluation for "breast growth" will be candidates to participate in this study. Patients with history of elevated blood pressure and who are already on anti-hypertensives would be ideal candidates for this project. In such situation, hydralazine will replace other anti-hypertensives. There is no age limit for this study. Inclusion criteria are as follows:

1. Operable "invasive" breast cancer

2. Signed informed consent

3. Baseline blood pressure OFF antihypertensives > 110/60 mmHg

Exclusion Criteria:

1. Pre-existing hypotension

2. Pre-existing liver disease (liver function tests > 2x upper limits of normal ULM).

3. Pre-existing kidney (serum creatinine > 2 mg/dl).

4. Medical necessity to remain on beta-blockers that cannot be met by other agents.