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
  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:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The time from patient entry into the protocol to death by any cause.


Enrollment: 4
Study Start Date: November 2008
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: June 22, 2016
Last Updated: June 22, 2016
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
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

ClinicalTrials.gov processed this record on August 23, 2016