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

NCT ID: NCT00832871

Last Updated: 2018-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2015-12-31

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

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mifepristone

200 mg RU-486 (Mifepristone) daily

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Mifepristone 200 mg will be administered orally

Interventions

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Mifepristone

Mifepristone 200 mg will be administered orally

Intervention Type DRUG

Other Intervention Names

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RU-486; Mifeprex

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Feminist Majority Foundation

OTHER

Sponsor Role collaborator

New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fa-Chyi Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Cancer Center

Locations

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Universtiy of New Mexico - Cancer Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Related Links

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http://www.cancer.unm.edu

University of New Mexico Cancer Center

http://www.nmcca.org

New Mexico Cancer Care Alliance

Other Identifiers

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NCI-2011-02682

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 0817

Identifier Type: -

Identifier Source: org_study_id

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