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Monthly SOM230C for Recurrent or Progressive Meningioma
This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, March 2009
First Received: March 9, 2009   Last Updated: March 27, 2009   History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00859040
  Purpose

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.


Condition Intervention Phase
Meningioma
Drug: SOM230C
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the activity of pasireotide LAR monotherapy as measured by PFS6, in patients with recurrent or progressive meningiomas [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the response rate, median PFS, median overall survival, and time to progression in this population [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To characterize the safety and tolerability of pasireotide LAR [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SOM230C
    Injection in the buttocks every 28 days
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.
  • 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; EKG; blood samples and a pregnancy test (for women of child-bearing potential).
  • In the middle of the first two cycles (around day 15), participants will visit the research doctor for a complete physical examination including a neurological exam and blood work.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 if the tumor is not surgically accessible. Patients with neurofibromatosis type 2 and a classic radiographic picture of meningioma may also enroll without histological confirmation

  • At least ten unstained 10 micron paraffin slides for immunohistochemistry. Participants whose tumor is not surgically accessible 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 > 470 msec
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859040

Contacts
Contact: Patrick Y. Wen, MD 617-632-2166 pwen@partners.org
Contact: Samantha Hammond 617-632-5396

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sceppa Christine, BA     617-632-6684     Christine_Sceppa@DFCI.harvard.edu    
Principal Investigator: Patrick Y. Wen, MD            
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nancy Shearer, RN     617-726-7851     nshearer@partners.org    
Principal Investigator: Scott R. Plotkin, MD, PhD            
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Lauren Abrey, M.D.     212-639-5122     abreyl@MSKCC.org    
United States, North Carolina
Wake Forest University Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Glenn Lesser, MD     336-716-9527     glesser@wfubmc.edu    
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Investigators
Principal Investigator: Patrick Y. Wen, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Dana-Farber Cancer Institute ( Patrick Wen, MD )
Study ID Numbers: 08-266, CSOM230CUS09T
Study First Received: March 9, 2009
Last Updated: March 27, 2009
ClinicalTrials.gov Identifier: NCT00859040     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
recurrent intracranial meningioma(s)
progressive intracranial meningioma(s)

Study placed in the following topic categories:
Meningeal Neoplasms
Meningioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Recurrence

Additional relevant MeSH terms:
Meningeal Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningioma
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009