Monthly SOM230C for Recurrent or Progressive Meningioma (NCT00859040) | Clinical Trial Compass
CompletedPhase 2
Monthly SOM230C for Recurrent or Progressive Meningioma
United States34 participantsStarted 2009-03
Plain-language summary
The purpose of this research study is to evaluate the effectiveness and safety of SOM230C in treating recurrent meningiomas. SOM230C is a newly discovered drug that may stop meningioma cells from growing abnormally. This drug has been used in treatment of other tumors, and information from those other research studies suggests that SOM230C may help to stop the growth of meningiomas.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years of age or older
* Radiographically measurable disease on contrast-enhanced MRI or CT images
* Karnofsky Performance status of 60 or greater
* Life expectancy of at least 3 months
* Histologically confirmed diagnosis of recurrent or progressive intracranial meningioma(s). This includes benign, atypical, or malignant meningioma; patients with neurofibromatosis type 1 or 2 may participate. Participants without histological confirmation but a classic radiographic picture of meningioma may also enroll. Patients with neurofibromatosis type 2 and a classic radiographic picture of meningioma may also enroll without histological confirmation
* At least ten unstained standard (4-5 micron) paraffin slides for immunohistochemistry. Participants who have not had a surgical procedure are exempt from this requirement
* Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is contraindicated)
* MRI or CT must be performed within 14 days of registration
* Patients with malignant meningiomas who require corticosteroids must be on a stable dose for at least 5 days prior to baseline imaging.
* For patients who have been treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval of 4 or more weeks must have elapses from the completion of radiation therapy to study drug administration, and there must be evidence of tumor progression.
* There is no limit on the number of prior therapies
Exclusion Criteria:
* Any cy…