Monthly SOM230C for Recurrent or Progressive Meningioma
Condition: Meningioma
MeSH terms: Meningioma
Intervention: SOM230C
Intervention description: Injection in the buttocks every 28 days
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent intracranial meningioma(s); progressive intracranial meningioma(s)

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.
    

Eligibility criteria:

        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