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Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma

- To enroll in the study, a sample of the participant's tumor tissue, stored from an
earlier study, must be sent to a lab at the Dana-Farber/Harvard Cancer Center for
diagnosis and special testing.

- Prior to starting the study medication, participants will undergo a Octreotide scan.
This is a special type of scan used to obtain information about certain tumors.

- Participants will receive the study medication, SOM230C, via an injection into the
buttocks every 28 days. Therefore, each treatment cycle lasts 28 days.

- The following tests and procedures will be done prior to the first, second and third
treatment cycles, and every three treatment cycles thereafter: Complete physical
examination including neurological exam; vital signs; current medication and symptom
review; blood samples and a pregnancy test (for women of child-bearing potential).

- About 2/3 through the first treatment cycle (around day 22), participants will visit
the research doctor for a complete physical examination including a neurological exam
and blood work.

- Participants will have ECGs done prior to their first treatment cycle, about 2/3
through the first and third treatment cycles (around day 22), prior to their sixth
treatment cycle, and every three treatment cycles thereafter.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the activity of pasireotide LAR monotherapy as measured by PFS6, in patients with recurrent or progressive meningiomas

Outcome Time Frame:

6 mths

Safety Issue:


Principal Investigator

Patrick Y. Wen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

December 2013

Related Keywords:

  • Meningioma
  • recurrent intracranial meningioma(s)
  • progressive intracranial meningioma(s)
  • Meningioma



Memorial Sloan Kettering Cancer Center New York, New York  10021
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cedars-Sinai Medical Center Los Angeles, California  90048
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Northwestern University Chicago, Illinois  60611
Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157
Duke University Medical Center, Preston Robert Tisch Brain Tumor Center Durham, North Carolina  27710