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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02682 | Registry Identifier | NCI CTRP |
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Low accrual; 4 patients enrolled between 2008-2015
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| Name | Class |
|---|---|
| The Feminist Majority Foundation | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Experimental | 200 mg RU-486 (Mifepristone) daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Mifepristone 200 mg will be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The time from patient entry into the protocol to death by any cause. | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fa-Chyi Lee, M.D. | University of New Mexico Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtiy of New Mexico - Cancer Center | Albuquerque | New Mexico | 87106 | United States |
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| Label | URL |
|---|---|
| University of New Mexico Cancer Center | View source |
| New Mexico Cancer Care Alliance | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mifepristone | 200 mg RU-486 (Mifepristone) daily Mifepristone: Mifepristone 200 mg will be administered orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mifepristone | 200 mg RU-486 (Mifepristone) daily Mifepristone: Mifepristone 200 mg will be administered orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Only one patient achieved stable disease. This patient's duration of response could therefore be reported. The other three patients progressed on treatment. | Posted | Median | Full Range | days | 5 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mifepristone | 200 mg RU-486 (Mifepristone) daily Mifepristone: Mifepristone 200 mg will be administered orally |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema: limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
This is a compassionate use protocol. No statistical analysis was specified in the protocol; it states that only descriptive data will be collected. Data from only 4 patients should not be considered reliable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fa-chyi Lee | University of New Mexico Comprehensive Cancer Center | 505-925-0405 | FLee@salud.unm.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Mifepristone | 200 mg RU-486 (Mifepristone) daily Mifepristone: Mifepristone 200 mg will be administered orally |
|
|
| 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. | All patients received at least one dose of study medication and are included in this analysis. | Posted | Number | percentage of participants | Up to 8 weeks after the end of study treatment or until any adverse events are resolved (whichever is longest) |
|
|
|
| Other Pre-specified | Overall Survival | The time from patient entry into the protocol to death by any cause. | Posted | Median | Standard Deviation | Months | 5 years |
|
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| Edema: trunk | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Watery eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diplopia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D011083 |
| Polycyclic Compounds |
| Title | Measurements |
|---|
|
| Dizziness |
|
| Fatigue |
|
| Anorexia |
|
| Skin Rash |
|