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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832871
Recruitment Status : Terminated (Low accrual; 4 patients enrolled between 2008-2015)
First Posted : January 30, 2009
Results First Posted : August 2, 2016
Last Update Posted : June 29, 2018
The Feminist Majority Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Mifepristone Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: INST 0817: Compassionate Use of Mifepristone
Study Start Date : November 2008
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mifepristone
200 mg RU-486 (Mifepristone) daily
Drug: Mifepristone
Mifepristone 200 mg will be administered orally
Other Name: RU-486; Mifeprex

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Toxicity Associated With Adrenal Insufficiency [ Time Frame: Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest) ]
    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.

Other Outcome Measures:
  1. Overall Survival [ Time Frame: 5 years ]
    The time from patient entry into the protocol to death by any cause.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832871

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United States, New Mexico
Universtiy of New Mexico - Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
The Feminist Majority Foundation
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Principal Investigator: Fa-Chyi Lee, M.D. University of New Mexico Cancer Center
Additional Information:
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Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT00832871    
Other Study ID Numbers: INST 0817
NCI-2011-02682 ( Registry Identifier: NCI CTRP )
First Posted: January 30, 2009    Key Record Dates
Results First Posted: August 2, 2016
Last Update Posted: June 29, 2018
Last Verified: May 2018
Keywords provided by New Mexico Cancer Care Alliance:
Compassionate Use
Additional relevant MeSH terms:
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Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents