Skip to main content
OpenTrials
Completed

NCT Number: NCT00261391

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Childrens Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

marimastat

Drug

Primary outcomes

  1. History

  2. Physical Examination

  3. Laboratory studies

  4. Vital Signs

  5. EKG

  6. Urine studies

Secondary outcomes

  1. Individualized. Change in the predetermined measure of the vascular anomaly.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Phase I Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of Marimastat in Patients With Disabling Malformations and No Other Treatment Options

Important dates

Study start
2000
Study completion
2007
First posted
Dec 5, 2005
Registry last updated
Jan 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.