Clinical trial NCT00859040: Monthly SOM230C for Recurrent or Progressive Meningioma
Official title: Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningioma
Keywords: recurrent intracranial meningioma(s)
progressive intracranial meningioma(s)
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Memorial Sloan Kettering Cancer Center
name: Wake Forest University Health Sciences
name: Duke University
name: Cedars-Sinai Medical Center
name: Northwestern University
name: Novartis
First posted: 2009-03-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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; 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.

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

Primary outcomes:
measure: 6 Month Progression Free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Response Rate
timeFrame: 5 years
measure: Treatment-related Events
timeFrame: 5 years
measure: Median Progression-Free Survival
timeFrame: 5 years
measure: Median Time to Progression
timeFrame: 34 months
measure: Overall Survival
timeFrame: 34 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center, Preston Robert Tisch Brain Tumor Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Patrick Y. Wen, MD
role: PRINCIPAL_INVESTIGATOR
References: