Clinical Trial: Mifepristone in Meningioma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma

Brief Summary: To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.

Detailed Summary: To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma and to address issues of safety in this patient population.
Sponsor: Southwest Oncology Group

Current Primary Outcome: Time to Treatment Failure [ Time Frame: 6 years ]

From date of registration to first date of documentation of one of the following:

  1. Progression (clear worsening of evaluable disease must be confirmed by 2 investigators).
  2. Significant deterioration of at least one neurologic symptom
  3. Discontinuation of treatment for any reason.
  4. Death from any cause.


Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of Treatment-Emergent Adverse Events [ Time Frame: two years after beginning treatment ]

Patients will be followed for adverse events as defined by the SWOG toxicity criteria


Original Secondary Outcome: Safety [ Time Frame: two years after beginning treatment ]

Patients will be followed for adverse events as defined by the SWOG toxicity criteria


Information By: Southwest Oncology Group

Dates:
Date Received: January 6, 2017
Date Started: August 1992
Date Completion:
Last Updated: January 9, 2017
Last Verified: January 2017