Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

The University of Chicago

Status

Terminated

Conditions

Treatment Induced Hypertension

Treatments

Drug: Minoxidil

Drug: Hydralazine

Study type

Interventional

Funder types

Other

Identifiers

NCT00607477

15386B

Details and patient eligibility

About

The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ongoing treatment for malignancy by at the University of Chicago with any agent with recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.
Treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmHg.
Stable management of other toxicities from the cancer treatments
Expected to continue current cancer treatments for at least 4 weeks
18 years and older
Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.

Exclusion criteria

Concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
Current uncontrolled toxicities due to the cancer treatments.
Patients having known contraindications to hydralazine or minoxidil therapy.
Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg in the four (4) weeks prior to screening.
Use of either minoxidil or hydralazine in the six (6) months prior to screening.