SOM230-C TRIAL for Meningioma Patients Who Have Previously Undergone or Are Not Candidates for Additional Surgery or Radiation
PHASE II STUDY OF MONTHLY SOM230C FOR RECURRENT OR PROGRESSIVE MENINGIOMA (IRB#19611)
Meningiomas are primary brain tumors that arise from the meninges, the covering of the brain. After gliomas, meningiomas are the most common primary brain tumors in adults. Surgical removal is the treatment of choice for meningiomas, however, depending on the condition of the patient and/or location of the tumor, complete removal of the tumor may not be an option. Patients who are not eligible for complete removal of the tumor or who have a high grade tumor have a high likelihood of tumor recurrence. As a result, there is a large number of adult patients with recurrent meningiomas who have limited treatment options.
Standard treatment for malignant meningiomas includes radiation and chemotherapy. Different chemotherapy agents have been offered as treatment options, however none have showed consistent benefit.
This subject population consists of patients with meningioma that have been treated with standard of care radiation and chemotherapy and have recurred. Patients in this study are not eligible for further surgical resection or chemotherapy. Treatment alternatives include treatment with steroids or no treatment.
SOM230 is an investigational drug administered by injection (it is a somatostatin analogue) that is currently being developed for treatment of meningioma. Meningiomas have many types of surface receptors. Among these somatostatin receptors are widespread. SOM230 binds to somatostatin receptors, which many studies have shown to shrink or slow the growth of meningiomas and have suggested as a potential treatment for recurrent meningiomas.
The purpose of this research is to evaluate the effectiveness and safety of SOM230 in treating meningiomas that have come back. This study seeks to offer patients with recurrent or advanced meningioma with limited treatment options an alternative therapy.
Potential subjects will be identified by a PI or sub Investigators through a clinic visit or an outside referral and an Informed Consent Form will be given to them. If a potential subject is referred by an outside physician a copy of the Informed consent will be given to the referring physician. Interested individuals will then be encouraged to discuss with his/her referring physician.
A separate appointment will be scheduled as an initial visit at the Neurosurgical Institute. On that visit potential subjects will be given a chance to ask questions regarding the study to the PI or the Sub Investigator.
Additionally, to enroll in this study, a sample of tumor tissue, stored from an earlier surgery, must be sent to a lab at the Dana-Farber/Harvard Cancer Center for diagnosis and special testing to learn how the study drug might bind to certain types of receptors are on the tumor surface. Patients who have had a prior surgery to remove tumor and have no tumor tissue available will be ineligible to participate in this study. Patients with an inoperable tumor are exempt from this requirement as are patients with benign meningiomas who choose not to have surgery. The sample sent to the Dana-Farber/Harvard Cancer Center will be de-identified. Subjects also have the opportunity to participate in a sub-study which asks them to provide a portion of their tumor for future research related to this disease. Subjects will sign a separate consent form for this sub-study portion of the trial.
Once all questions are answered by the PI or Sub Investigator Informed Consent will be obtained.
Forty patients will take part in this study, approximately 8 subjects at CSMC. Patients will receive intramuscular (into the muscle) injections of 60mg of SOM230 every 28 days.
Each subject will come in for 6 visits (in addition to baseline and screening visits) over the period of one year. Each cycle is 28 days. Subjects will be asked to come in on Day 1 and 15 of the first two cycles and Day 1 of cycle 3, 6, 9 and 12. Study evaluation will be performed every three treatment cycles for the first twelve cycles of therapy and every six cycles thereafter for the duration of treatment with SOM230. Subjects may choose to have Day 1 of Cycle 22 visit performed by their local neurologist if it is more convenient to having this visit at CSMC.
The study will involve standard of care and research related procedures. The following procedures are considered standard of care: medical history, physical and neurologic exam (including KPS and MMSE), recording medications, height, weight, vitals signs, brain MRI w/and w/out contrast, and blood tests. The following are considered research related procedures: maintenance of daily study drug administration, electrocardiogram, gallbladder ultrasound, octreotide scan, and pregnancy test. If any of electrocardiogram results show a lengthening of the hearts electrical cycle it may be necessary to be evaluated further by a heart specialist and undergo a 24 hour continuous ECG.
Note: Surveys and interviews such as the Mini Mental State Exam (MMSE) and Karnofsky Performance Status (KPS) are considered standard of care for this population.
Surasak Phuphanich, MD, FAAN
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