INST 0817: Compassionate Use of Mifepristone
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Duration of Response
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mifepristone
200 mg RU-486 (Mifepristone) daily
Intervention: Mifepristone (Drug)
Outcomes
Primary Outcomes
Duration of Response
Time Frame: 5 years
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
Secondary Outcomes
- Toxicity Associated With Adrenal Insufficiency(Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest))