Intra-Arterial Methylprednisolone Treatment: A Phase II Study

What we are studying

The purpose of this research study is to determine the additional benefit (standard therapy is also given) of glucocorticoids (“steroids”) injected directly into the arteries that supply the parts of your gastrointestinal tract affected by acute GvHD. Since standard therapy produces satisfactory resolution in less than half the cases, new options must be considered. One such option is the injection of the most proven agents, glucocorticoids (specifically methylprednisone [Solu-Medrol]), directly into the arteries that supply the gastrointestinal tract. This method has been helpful in some patients with GvHD that did not respond to primary therapy with glucocorticoids and might work better when used in addition to standard therapy earlier in the course of GvHD.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Must have diagnosis of de novo acute Graft vs. Host Disease and classified as "high risk"
  • You cannot be receiving any other durgs for the treatment of GvHD
  • You cannot have an uncontrolled severe infection
  • You cannot be pregnant

What is involved

  • Exam
  • Blood work
  • CT scan of abodmen and pelvis
  • Endoscopy upper and lower gastrointestinal
  • Arterial steroid injections

Compensation

Parking validation will be provided for study-related visits

Contact Information

Study Coordinator
Suzanne Carroll
Email
scarroll@wakehealth.edu
Phone
336-713-5719

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.