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:
- Progression (clear worsening of evaluable disease must be confirmed by 2 investigators).
- Significant deterioration of at least one neurologic symptom
- Discontinuation of treatment for any reason.
- 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 ]
Original Secondary Outcome: Safety [ Time Frame: two years after beginning treatment ]
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