Status:
TERMINATED
Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension
Lead Sponsor:
University of Chicago
Conditions:
Treatment Induced Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00607477
Start Date
January 1 2008
End Date
January 1 2009
Last Update
June 10 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637