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S9005 Mifepristone in Meningioma

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ClinicalTrials.gov Identifier: NCT03015701
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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

Condition or disease Intervention/treatment Phase
Meningioma Drug: Mifepristone Other: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind Randomized Trial of the Anti-Progestational Agent Mifepristone In The Treatment of Unresectable Meningioma
Study Start Date : August 1992
Actual Primary Completion Date : October 2001
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Mifepristone 200 mg orally daily for two years
Drug: Mifepristone
a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor
Other Name: RU-486

Placebo Comparator: Arm 2
Placebo orally daily for two years
Other: Placebo
placebo matching mifepristone




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: two years after beginning treatment ]
    Patients will be followed for adverse events as defined by the SWOG toxicity criteria



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have a histologically documented primary, recurrent or residual meningioma which is unresectable.
  2. Patients must have active meningioma, which is defined to be one of the following:

    1. Progressive disease within the past 2 years.
    2. Recurrent Disease, as defined by the reappearance of a previously completely resected meningioma, within the past two years.
    3. New disease, defined as a diagnosis of meningioma within the previous two years
  3. Patients must have measurable or evaluable disease which is documented on CT or MRI scan.
  4. 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.
  5. Patients must be 18 years or older, and must have a performance status 0-2 by Southwest Oncology Group criteria.
  6. Patients must not have received prior cytotoxic chemotherapy for meningioma.
  7. Patients must have serum creatinine, SGOT, and bilirubin ≤ 2 x IULN.
  8. 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.
  9. Patients receiving anti-epileptic medications are eligible. However barbiturates should be avoided if possible.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. Patients with clinical adrenal insufficiency requiring exogenous corticosteroid replacement are not eligible.
  15. Patients with a known allergy to mifepristone are not eligible.
  16. Patients with base of brain, cavernous sinus or optic nerve meningiomas or with visual symptoms must have a formal visual field examination.
  17. 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.
  18. 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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015701


Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Director: Charles Blanke, MD Oregon Health and Sciences University

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT03015701     History of Changes
Other Study ID Numbers: SWOG-9005
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://swog.org/Visitors/Download/Policies/Policy43.pdf

Keywords provided by Southwest Oncology Group:
Unresectable

Additional relevant MeSH terms:
Meningioma
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
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