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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the activity of pasireotide LAR monotherapy as measured by PFS6, in patients with recurrent or progressive meningiomas
Patrick Y. Wen, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|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|