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

This study has been terminated.
(Low accrual; 4 patients enrolled between 2008-2015)
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: June 22, 2016
Last verified: June 2016

January 29, 2009
June 22, 2016
November 2008
December 2015   (final data collection date for primary outcome measure)
Duration of Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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
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
Toxicity Associated With Adrenal Insufficiency [ Time Frame: Up to 8 weeks after the end of study treatment ] [ Designated as safety issue: Yes ]
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.
To record outcomes of patients while they are taking mifepristone [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The time from patient entry into the protocol to death by any cause.
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.
 
Terminated
4
December 2015
December 2015   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00832871
INST 0817, NCI-2011-02682
No
Not Provided
Not Provided
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
June 2016

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