Monthly SOM230C for Recurrent or Progressive Meningioma

NCT00859040 | Completed Phase 2 Results DMC

• 2 other identifiers: 08-266CSOM230CUS09T
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

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.

Conditions

Meningioma

Keywords

recurrent intracranial meningioma(s); progressive intracranial meningioma(s)

Outcome Measures

Primary Outcomes (1)

• 6 Month Progression Free Survival

  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).

  6 months

Secondary Outcomes (5)

• Response Rate

  5 years

• Treatment-related Events

  5 years

• Median Progression-Free Survival

  5 years

• Median Time to Progression

  34 months

• Overall Survival

  34 months

Study Arms (1)

SOM230C

EXPERIMENTAL

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

Drug: SOM230C

Interventions

SOM230C DRUG

Injection in the buttocks every 28 days

Also known as: pasireotide LAR

SOM230C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Patrick Y. Wen, MD: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Wake Forest University Health Sciences: collaborator
• Duke University: collaborator
• Cedars-Sinai Medical Center: collaborator
• Northwestern University: collaborator
• Novartis: collaborator

Study Sites (8)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center, Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Results Point of Contact

• Title: Patrick Y. Wen, MD
• Organization: Dana-Farber Cancer Institute / Brigham & Women's Hospital

pwen@partners.org

617-632-2166

Study Officials

• Patrick Y. Wen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Directory, Center for Neuro-Oncology

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2016
• Last Updated: October 27, 2017
• Results First Posted: May 16, 2014

Record last verified: 2017-09

Locations

US (8)