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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
The Feminist Majority Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00832871
First received: January 29, 2009
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Cancer
Drug: Mifepristone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: INST 0817: Compassionate Use of Mifepristone

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 5 months or longer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 5 months or longer ] [ Designated as safety issue: Yes ]
    Evaluate patients for possible adrenal insufficiency (by reports of nausea, vomiting, lethargy, dizziness, fatigue, and anorexia)and possible development of skin rash.


Estimated Enrollment: 10
Study Start Date: November 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone
200 mg RU-486 (Mifepristone) daily
Drug: Mifepristone
Mifepristone 200 mg will be administered orally
Other Name: RU-486; Mifeprex

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832871

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:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832871     History of Changes
Other Study ID Numbers: INST 0817, NCI-2011-02682
Study First Received: January 29, 2009
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico Cancer Care Alliance:
Mifepristone
RU-486
Compassionate Use
Antiprogesterone

Additional relevant MeSH terms:
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 14, 2014