Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00261391
First received: December 2, 2005
Last updated: January 8, 2008
Last verified: May 2005

December 2, 2005
January 8, 2008
October 2000
Not Provided
  • History
  • Physical Examination
  • Laboratory studies
  • Vital Signs
  • EKG
  • Urine studies
Same as current
Complete list of historical versions of study NCT00261391 on ClinicalTrials.gov Archive Site
Individualized. Change in the predetermined measure of the vascular anomaly.
Same as current
Not Provided
Not Provided
 
Phase I Drug Trial for S/E of Marimastat in Disabling Malformations When no Other Options.
Phase I Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Marimastat in Patients With Disabling Malformations and No Other Treatment Options

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 patients. Efficacy measures were individualized as enrolllees do not have the same underlying vascular anomaly. The study is structured to include a 24 month drug-phase and a 24 month follow-up phase. The study is now closed to enrollment.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Anomalies
Drug: Marimastat
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2007
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00261391
03-04-052R
Not Provided
Not Provided
Children's Hospital Boston
Not Provided
Principal Investigator: Steven J Fishman, M.D. Children's Hospital Boston
Children's Hospital Boston
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP