S9005 Mifepristone in Meningioma

NCT03015701 | Completed Phase 3 DMC

• 2 other identifiers: SWOG-9005U10CA032102
• Study Type: interventional
• Target: 193
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare daily oral mifepristone vs placebo with respect to time to treatment failure in patients with unresectable meningioma.

Conditions

Meningioma

Keywords

Unresectable

Outcome Measures

Primary Outcomes (1)

• Time to Treatment Failure

  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.

  6 years

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  two years after beginning treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

Mifepristone 200 mg orally daily for two years

Drug: Mifepristone

Arm 2

PLACEBO COMPARATOR

Placebo orally daily for two years

Other: Placebo

Interventions

Mifepristone DRUG

a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor

Also known as: RU-486

Arm 1

Placebo OTHER

placebo matching mifepristone

Arm 2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

MeSH Terms

Conditions

Meningioma

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Charles Blanke, MD

  Oregon Health and Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: August 1, 1992
• Primary Completion: October 1, 2001
• Study Completion: November 1, 2012
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share