MeningiomaPhase 3NCT03015701
S9005 Mifepristone in Meningioma
A Phase 3 study testing Mifepristone in people with Meningioma, run by SWOG Cancer Research Network.
Trial summary
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Meningioma
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- No sites listed yet
- Study dates
- Aug 1992to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically documented primary, recurrent or residual meningioma which is unresectable.
- Patients must have active meningioma, which is defined to be one of the following:
- Progressive disease within the past 2 years.
- Recurrent Disease, as defined by the reappearance of a previously completely resected meningioma, within the past two years.
- New disease, defined as a diagnosis of meningioma within the previous two years
- Patients must have measurable or evaluable disease which is documented on CT or MRI scan.
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- Patients should have already received radiotherapy unless radiotherapy is inappropriate due to tumor location(s) or unless radiotherapy, after discussion with the patient's physician, has been refused. If patients have received prior radiotherapy, this treatment must have been completed more than one year prior to study entry with documented progressive disease since completion of radiotherapy.
- Patients must be 18 years or older, and must have a performance status 0-2 by Southwest Oncology Group criteria.
- Patients must not have received prior cytotoxic chemotherapy for meningioma.
- Patients must have serum creatinine, SGOT, and bilirubin ≤ 2 x IULN.
- Patients requiring simultaneous administration of corticosteroids for cerebral edema must have been receiving a stable dose of corticosteroids for at least 4 weeks prior to study entry.
- Patients receiving anti-epileptic medications are eligible. However barbiturates should be avoided if possible.
- Patients with meningiomatosis (diffuse meningeal infiltration resulting in only nonevaluable meningeal thickening) are not eligible. However, patients with multiple measurable or evaluable meningioma tumor masses are eligible.
- Patients with malignant meningioma are not eligible. Malignant meningioma is defined as meningioma that demonstrates hypercellularity, loss of architecture, nuclear pleomorphism, numerous mitoses, focal necrosis, and brain invasion.
- Patients who have had additive or ablative modulation of sex hormone or glucocorticoid pathways within the preceding 3 months (not including stable corticosteroid therapy for cerebral edema) are not eligible. Such modulations include but are not limited to birth control pills, bilateral oophorectomy or orchiectomy, progestational inserts, oral or vaginal exogenous estrogens, androgens or antiandrogens, progestational agonists, tamoxifen, aminoglutethimide, o,p-DDD, ACTH, glucocorticoids not for cerebral edema, and leuprolides (or other LH-RH inhibitors). Patients must not have received prior mifepristone therapy for meningioma.
- Patients must not have serious intercurrent medical illness; that is, any illness that in the opinion of the investigator would prevent following the study regimen.
- Patients with clinical adrenal insufficiency requiring exogenous corticosteroid replacement are not eligible.
- Patients with a known allergy to mifepristone are not eligible.
- Patients with base of brain, cavernous sinus or optic nerve meningiomas or with visual symptoms must have a formal visual field examination.
- Pregnant or lactating women may not participate. Pre-menopausal women and men of reproductive potential may not participate unless they have agreed to use an effective local contraceptive method (such as a condom, diaphragm, or IUD) or abstinence during and for 3 months after study therapy.
- Patients with other prior or concurrent malignancy within the preceding 5 years, except surgically treated squamous or basal cell skin cancer or cervical cancer in situ, are not eligible.
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Who cannot join
None listed.
About this study
Official title: Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.
Read the detailed description
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma and to address issues of safety in this patient population.
- Conditions
- Meningioma
- Being tested
- Mifepristone, Placebo
- Keywords
- Unresectable
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called RU-486
a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor
PlaceboOther
placebo matching mifepristone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Mifepristone 200 mg orally daily for two years Receives: Drug: Mifepristone |
| Arm 2 | Placebo comparator | Placebo orally daily for two years Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure
From date of registration to first date of documentation of one of the following:
- Progression (clear worsening of evaluable disease must be confirmed by 2 investigators).
- Significant deterioration of at least one neurologic symptom
- Discontinuation of treatment for any reason.
- Death from any cause.
Measured: 6 years
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Patients will be followed for adverse events as defined by the SWOG toxicity criteria
Measured: two years after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startAug 1992
- Primary completionOct 2001
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Blanke, MD, Study director, Oregon Health and Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015701
- Sponsor's protocol ID
- SWOG-9005
- Other IDs
- U10CA032102
- Status last verified
- Dec 2019
- First submitted
- 6 Jan 2017
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://swog.org/Visitors/Download/Policies/Policy43.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma
- ClinicalTrials.gov ID
- NCT03015701
- Acronym / sponsor ID
- SWOG-9005
- Conditions
- Meningioma
- Keywords
- Unresectable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1992
- Primary completion
- Oct 2001 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.
Detailed description
To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma and to address issues of safety in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: MifepristoneMifepristone 200 mg orally daily for two years |
| Arm 2 | Placebo comparator | Other: PlaceboPlacebo orally daily for two years |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients must have a histologically documented primary, recurrent or residual meningioma which is unresectable.
- Patients must have active meningioma, which is defined to be one of the following:
- Patients must have measurable or evaluable disease which is documented on CT or MRI scan.
- Patients should have already received radiotherapy unless radiotherapy is inappropriate due to tumor location(s) or unless radiotherapy, after discussion with the patient's physician, has been refused. If patients have received prior radiotherapy, this treatment must have been completed more than one year prior to study entry with documented progressive disease since completion of radiotherapy.
- Patients must be 18 years or older, and must have a performance status 0-2 by Southwest Oncology Group criteria.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneAlso: RU-486a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor | Drug | Arm 1 |
| Placeboplacebo matching mifepristone | Other | Arm 2 |
Primary outcome
Time to Treatment Failure
Time frame: 6 years
From date of registration to first date of documentation of one of the following: 1. Progression (clear worsening of evaluable disease must be confirmed by 2 investigators). 2. Significant deterioration of at least one neurologic symptom 3. Discontinuation of treatment for any reason. 4. Death from any cause.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: two years after beginning treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://swog.org/Visitors/Download/Policies/Policy43.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Blanke, MD study director
Oregon Health and Sciences University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone in people with Meningioma, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Failure (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.