Status:
COMPLETED
Monthly SOM230C for Recurrent or Progressive Meningioma
Lead Sponsor:
Patrick Y. Wen, MD
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Meningioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 grow...
Detailed Description
* 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. * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00859040
Start Date
March 1 2009
End Date
January 1 2016
Last Update
October 27 2017
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115