Status:
COMPLETED
Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.
Lead Sponsor:
Boston Children's Hospital
Conditions:
Vascular Anomalies
Eligibility:
All Genders
2+ years
Phase:
PHASE1
Brief Summary
3 patients were enrolled in each of 3 study cohorts. There three cohorts were given differing, incrementally larger doses of this phase I drug. The same safety measures are being obtained on all patie...
Eligibility Criteria
Inclusion
- Patient with vascular malformation causing risk of one or more of the following based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team.
- airway/respiratory/visual/auditory/neurologic compromise;
- high output cardiac failure;
- life-threatening or disabling hemorrhage(cutaneous/GI/intracranial/ parenchymal/cavitary);
- skeletal distortion/destruction/erosion;
- life-threatening or disabling soft tissue distortion or destruction
- Patient must be felt to have failed, be unable to significantly benefit from, or be at risk for other available therapies, including surgeries, embolization, and sclerotherapy based on unanimous assessment of designated physicians in the multidisciplinary Vascular Anomalies Team.
- Patient must be felt to have one or more physical, imaging, photographic, physiologic or other measurable features that can be measured on a regular basis for preliminary evaluation of efficacy. The feature(s) must be agreed on by the designated physicians in the multidisciplinary Vascular Anomalies Team).
- Signed Patient informed consent.
Exclusion
- Pregnancy
- Patient nursing child.
- Female patient of childbearing potential unwilling to receive contraceptive counseling and use reliable contraceptive method.
- Patient enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- Parent or guardian or child unwilling to provide consent or assent.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00261391
Start Date
October 1 2000
End Date
October 1 2007
Last Update
January 9 2008
Active Locations (1)
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1
Childrens Hospital
Boston, Massachusetts, United States, 02115