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

• ClinicalTrials.gov Identifier: NCT00832871
• Recruitment Status: Terminated
• First Posted: January 30, 2009
• Results First Posted: August 2, 2016
• Last Update Posted: June 29, 2018
• Sponsor: New Mexico Cancer Care Alliance
• Collaborator: The Feminist Majority Foundation
• Information provided by (Responsible Party): New Mexico Cancer Care Alliance

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Fa-Chyi Lee, M.D.; University of New Mexico Cancer Center

More Information

Additional Information:

University of New Mexico Cancer Center 

New Mexico Cancer Care Alliance 

• Responsible Party: New Mexico Cancer Care Alliance
• ClinicalTrials.gov Identifier: NCT00832871
• Other Study ID Numbers: INST 0817; NCI-2011-02682 ( Registry Identifier: NCI CTRP )
• First Posted: January 30, 2009
• Results First Posted: August 2, 2016
• Last Update Posted: June 29, 2018
• Last Verified: May 2018

Keywords provided by New Mexico Cancer Care Alliance:

Mifepristone; RU-486; Compassionate Use; Antiprogesterone

Additional relevant MeSH terms:

Mifepristone; 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