Compassionate Use of Mifepristone in Brain/Nervous System and Other Cancers

Study Overview
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Brief Summary
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The purpose of this study is to see if mifepristone prevents worsening of your cancer. Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is commonly used for the termination of pregnancies. It has not been approved by the Food and Drug Administration for use in the treatment of cancer. It is unlicensed in the United States for your condition. However, previous work has indicated that mifepristone may be useful due to how it works. It is being made available for use in the United States for compassionate use through the Feminist Majority Foundation.

Detailed Description
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This is a compassionate use of mifepristone treatment for patients with conditions that could respond to an antiprogesterone agent, including: Meningioma. Breast cancer Colon Cancer Endometrial Stromal Sarcoma Bilateral Chronic Central Serous Retinopathy Cushing's Syndrome Metastatic Adrenocortical Cancer Ovarian Cancer Other conditions as determined by the attending physicians

Official Title
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INST 0817: Compassionate Use of Mifepristone

Conditions
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Cancer

Intervention / Treatment
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* Drug: Mifepristone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients 18 years of age or older. Patients must sign an informed consent. Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks. Exclusion Criteria: Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone<br>200 mg RU-486 (Mifepristone) daily | Drug: Mifepristone<br>* Mifepristone 200 mg will be administered orally<br>* Other names: RU-486; Mifeprex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | The time from the date of response (not the beginning of treatment unless there is stable disease) to disease progression. Response and progression are evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity Associated With Adrenal Insufficiency | Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated using counts the following events of interest, which are related to possible adrenal insufficiency: nausea, vomiting, lethargy, dizziness, fatigue, anorexia, and skin rash. Any grade of these events that are self-reported by patients as well as events identified by physician assessment (e.g. physical exam) will be included. | Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mifepristone, RU-486, Compassionate Use, Antiprogesterone