Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma
Overview
- Phase
- Phase 2
- Intervention
- SOM230C
- Conditions
- Meningioma
- Sponsor
- Patrick Y. Wen, MD
- Enrollment
- 34
- Locations
- 8
- Primary Endpoint
- 6 Month Progression Free Survival
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Patrick Y. Wen, MD
Directory, Center for Neuro-Oncology
Dana-Farber/Brigham and Women's Cancer Center
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.
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
Arms & Interventions
SOM230C
Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)
Intervention: SOM230C
Outcomes
Primary Outcomes
6 Month Progression Free Survival
Time Frame: 6 months
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).
Secondary Outcomes
- Response Rate(5 years)
- Median Progression-Free Survival(5 years)
- Treatment-related Events(5 years)
- Median Time to Progression(34 months)
- Overall Survival(34 months)