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

INST 0817: Compassionate Use of Mifepristone

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Drug: Mifepristone

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Universtiy of New Mexico - Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone; 200 mg RU-486 (Mifepristone) daily	Drug: Mifepristone; Mifepristone 200 mg will be administered orally; Other Names: RU-486; Mifeprex

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	The time from patient entry into the protocol to death by any cause.	5 years

Collaborators and Investigators

• Sponsor: New Mexico Cancer Care Alliance
• Collaborators: The Feminist Majority Foundation
• Investigators: Principal Investigator: Fa-Chyi Lee, M.D., University of New Mexico Cancer Center

Publications and helpful links

Helpful Links

• University of New Mexico Cancer Center
• New Mexico Cancer Care Alliance

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: January 29, 2009
• First Posted (Estimate): January 30, 2009

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Compassionate Use; Mifepristone; RU-486; Antiprogesterone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: INST 0817; NCI-2011-02682 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No