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

Cancer Clinical Trial

Official title:

INST 0817: Compassionate Use of Mifepristone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00832871
• Other study ID #: INST 0817
• Secondary ID: NCI-2011-02682
• Status: Terminated
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2015

Study information

• Verified date: May 2018
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Mifepristone
Mifepristone 200 mg will be administered orally

Locations

Country	Name	City	State
United States	Universtiy of New Mexico - Cancer Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance	The Feminist Majority Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	The time from patient entry into the protocol to death by any cause.	5 years
Primary	Duration of Response	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	5 years
Secondary	Toxicity Associated With Adrenal Insufficiency	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.	Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest)

External Links

•   New Mexico Cancer Care Alliance
•   University of New Mexico Cancer Center