Monthly SOM230C for Recurrent or Progressive Meningioma

This is an interventional treatment trial for Meningioma focused on measuring recurrent intracranial meningioma(s), progressive intracranial meningioma(s) Read More

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 cytotoxic chemotherapy, radiation, immunotherapy, or experimental therapy within 4 weeks prior to study drug administration
• Prior therapy with somatostatin, andy somatostatin analogue, or any other hormonal treatment prescribed for the purpose of treating meningioma
• Major surgery within 4 weeks prior to study drug administration
• Malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
• Poorly controlled diabetes mellitus
• Symptomatic cholelithiasis
• Congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
• QTc > 450 msec
• Risk factors for Torsades de Pointes such as hypokalemia (< 3.5 mmol/L) not corrected by treatment, hypomagnesemia (< 0.7 mmol/L or < 1.6 mg/dL) not corrected by treatment, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
• Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
• Concomitant medication(s) known to increase the QT interval within 4 weeks prior to study drug administration
• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 2x ULN, serum albumin < 0.67 LLN, or ALT or AST more than 2 x ULN
• Any other primary malignancy within the past 3 years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
• Active or suspected acute or chronic, uncontrolled infection or any history of immunocompromise, including any positive HIV test result
• Abnormal coagulation studies (PT or PTT elevated by 30% above normal limits)
• Use of anticoagulant medications (not including anti-platelet medications)
• Lab values as specified in the protocol
• Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
• Pregnancy or lactation, or failure to practice a medically acceptable method of birth control
• History of alcohol or drug abuse in the 6 month period before study enrollment
• Participation in any clinical investigation with an investigational drug within 1 month prior to study drug administration
• Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR os s.c. formulations