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

January 29, 2009
March 3, 2014
November 2008
December 2014   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: 5 months or longer ] [ Designated as safety issue: No ]
To provide off-label use of mifepristone to patients with conditions where an antiprogesterone agent may have activity in preventing worsening of the condition [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00832871 on ClinicalTrials.gov Archive Site
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.
To record outcomes of patients while they are taking mifepristone [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cancer
Drug: Mifepristone
Mifepristone 200 mg will be administered orally
Other Name: RU-486; Mifeprex
Experimental: Mifepristone
200 mg RU-486 (Mifepristone) daily
Intervention: Drug: Mifepristone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
December 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832871
INST 0817, NCI-2011-02682
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
The Feminist Majority Foundation
Principal Investigator: Fa-Chyi Lee, M.D. University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP