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A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine


N/A
18 Years
N/A
Not Enrolling
Both
Treatment Induced Hypertension

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Trial Information

A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to and Magnitude of Change in Blood Pressure

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Michael Maitland, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

UCIRB 15386B

NCT ID:

NCT00607477

Start Date:

January 2008

Completion Date:

January 2009

Related Keywords:

  • Treatment Induced Hypertension
  • Hypertension

Name

Location

University of ChicagoChicago, Illinois  60637