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Pasireotide

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Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)

SOM230C

Patrick Y. Wen, MD

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.

* 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.

Monthly SOM230C for Recurrent or Progressive Meningioma

Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma

Progression is defined using Modified Macdonald Criteria , using a \>/= 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

Number of participants to experience complete or partial response on study treatment.

For response per Modified Macdonald Criteria, all measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.

1. Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.
2. Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. The steroid dose at the time of the scan evaluation should be no greater than the maximum dose used in the first 8 weeks from initiation of therapy.

All Grade 3-4-5 adverse events with a treatment attribution of probable, possible or definite based on CTCAE (v3.0) as reported on case report forms

Per protocol, the study's secondary objectives are to be evaluated "for the estimate of median ... PFS ... at time of interest." At this time, all study participants have been followed for progression for a minimum of 34 months (final patient to accrue to study was registered to trial on 06/14/2011), and study manuscript is currently being written-up with this information.

Percentage of participants alive 34 months after initiating study treatment. Median Overall Survival has not yet been reached for one study group; therefore, we are reporting Overall Survival rates by the end of the study time frame.

Brigham and Women's Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Memorial Sloan Kettering Cancer Center

Wake Forest University Health Sciences

Duke University

Cedars-Sinai Medical Center

Northwestern University

Novartis

Directory, Center for Neuro-Oncology

Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)

SOM230C: Injection in the buttocks every 28 days

participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days

Participants With Atypical/Malignant Meningiomas

participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days

Participants With Benign Meningiomas

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

White, Non-Hispanic

Black or African American, Non-Hispanic

Hispanic or Latino (Unknown Race)

White (Unknown Ethnicity)

Race/Ethnicity, Customized

100% = Normal; 90% = Normal activity, minor signs/symptoms; 80% = Normal activity w/ effort, some signs/symptoms; 70% = Cares for self, unable to do normal activity/active work; 60% = Requires occasional assistance, but cares for most personal needs; 50% = Requires considerable assistance/frequent medical care; 40% = Disabled, requires special care \& assistance; 30% = Severely disabled, hospital admission is indicated but death not imminent; 20% = Very sick, hospitalization necessary, active supportive treatment necessary; 10% = Moribund, fatal processes progressing rapidly; 0% = Dead.

KPS scores

6 Month Progression Free Survival

Response Rate

Amylase

Fatigue

Hyperglycemia

Hypoglycemia

Hypokalemia

Lipase

Treatment-related Events

Median Progression-Free Survival

Time to progression only reported for the 32 patients who have progressed (either on treatment or in follow-up).

\[NOTE: The other 2 patients who were treated on study each remain progression-free after \> 1000 days.\]

Median Time to Progression

Overall Survival

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Monthly SOM230C for Recurrent or Progressive Meningioma	NCT00859040	Meningioma	SOM230C	18 Years -	Dana-Farber Cancer Institute
Monthly SOM230C for Recurrent or Progressive Meningioma	NCT00859040	Meningioma	SOM230C	18 Years -	Dana-Farber Cancer Institute
Monthly SOM230C for Recurrent or Progressive Meningioma	NCT00859040	Meningioma	SOM230C	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for progressive intracranial meningioma(s)