Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysm
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on 2007-03-02
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain Arteriovenous Malformations; Brain Aneurysms
Intervention: Minocycline and doxycycline (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting. Expecting to enroll 122 people.
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
William L. Young, M.D., Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Nancy J. Quinnine, RN, Phone: 415/476-2677, Email: quinnine@anesthesia.ucsf.edu
Summary
Cerebrovascular malformations represent a potentially life-threatening disorder of the central nervous system. Spontaneous hemorrhage rates accompanied by a significant risk of death and disability, are on the order of 2-6% per year, which is cumulative over the life of the patient. Further, there remains a small but significant subset of patients who are not surgical candidates because of an extremely high treatment risk, e. g., those with lesions that are very large or locted in inaccessible areas of the brain. Further, there are patients who have undergone partial treatment who are not protected from spontaneous ICH, e. g., those undergoing partial endovascular embolization. This study will investigate the use of minocycline or doxycycline as medical therapy. These drugs can induce biologically significant changes in an enzyme system thought to be related to spontaneous growth and rupture of vascular malformations. In addition, it will be shown that taking minocycline or doxycycline over an extended period in this patient population is safe and well tolerated.
Clinical Details
Official title:
Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
Study design: Interventional, Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome:
Detailed description:
As above.
Eligibility
Minimum age: 13 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 1) Giant aneurysm or BAVM patients who will not be undergoing surgical therapy. 2) Female patients of child bearing age using effective birth control or males. 3) Creatinine no greater than 2. 0 mg/dl 4) Alanine aminotransferase (ALT) no greater than 2 times upper limit of control.
5) WBC count at least 3,800/mm3. 6) 13 years and older 7) BMI within 30% of normal
Exclusion Criteria:
1) Unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
2) Contrandications to tetracyclines including allergy or other intolerance.
3) History of vestibular disease (except benign positional vertigo)
4) Prior tetracycline ise with 2 months of baseline visit.
5) History of noncompliance with treatment or other experimental protocols.
6) History of systemic lupus erythematosis
7) Patients that are not candidates for MRI studies -
Locations and Contacts
Nancy J. Quinnine, RN, Phone: 415/476-2677, Email: quinnine@anesthesia.ucsf.edu
University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
Nancy J. Quinnine, RN, Phone: 415-476-2677, Email: quinnine@anesthesia.ucsf.edu
William L. Young, MD, Phone: 415/206-8906, Email: youngw@anesthesia.ucsf.edu
William L. Young, MD, Principal Investigator
Additional Information
Center for Cerebrovascular Research
Starting date:
July 2004
Last updated: September 18, 2006
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