Full Text View
Tabular View
No Study Results Posted
Related Studies
Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma
This study is ongoing, but not recruiting participants.
First Received: November 17, 2008   Last Updated: April 8, 2009   History of Changes
Sponsors and Collaborators: University of Utah
Novartis
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00813592
  Purpose

This is a single-arm, phase II trial of SOM230 in patients with documented recurrent or progressive intracranial meningioma who have failed conventional therapy and are not candidates for complete surgical resection of their tumors and/or radiation at the time of study entry.

At the time of the final analysis, all patients who are receiving treatment with SOM230 will complete the core phase of the study and will continue on the extension phase. During this time, additional data on response duration, PFS, and safety will be collected.


Condition Intervention Phase
Cancer
Drug: SOM230B
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: A Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma Who Have Previously Undergone or Are Not Candidates for Additional Surgery or Radiation

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • determine objective response rate (ORR) ( [CR] plus [PR]) of SOM230 monotherapy in meningioma [ Time Frame: November 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the duration of response to SOM230 [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • To establish the 6-month progression-free survival rate [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • To establish the median PFS and overall survival (OS) [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • To determine the clinical benefit rate (CR + PR + stable disease) of SOM230 [ Time Frame: November 2010 ] [ Designated as safety issue: No ]
  • To characterize the safety and tolerability of SOM230 [ Time Frame: November 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: November 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SOM230B

    SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5.

    Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 18 years or greater.
  2. Patients with radiographically measurable disease and histologically confirmed recurrent or progressive intracranial meningiomas (refer to Appendix 1) who are not candidates for complete surgical resection of their tumors because the tumors are in eloquent areas of the brain (near critical neural structures)or are not candidates for cranial irradiation because a) they have already received radiation or b) the tumor is in close proximity to the optic nerve and radiation would likely result in vision damage.
  3. Karnofsky Performance Status ≥ 60 (Requires occasional assistance, but is able to care for most of his/her personal needs.)
  4. Life expectancy > 3 months
  5. All standard serum electrolytes must not be clinically significant, as determined by PI. (Albumin, alkaline phosphatase, total bilirubin, calcium, chloride, creatinine, fasting blood glucose, potassium, total protein, SGOT, SGPT, sodium, and BUN)
  6. Serum chemistries are as follows: bilirubin ≤ 1.5 X ULN, ALT or AST ≤ 2.5 X ULN, BUN ≤ 1.5X ULN, creatinine ≤ 1.5 X ULN.
  7. Signed informed consent

Exclusion Criteria:

  1. Patients receiving any cytotoxic chemotherapy, radiation or immunotherapy within 4 weeks prior to study enrollment
  2. Patients who have undergone major surgery within 4 weeks(other than diagnostic surgery) or have not fully recovered, prior to study enrollment
  3. Patients with malabsorption syndrome, short bowel syndrome, or chologenic diarrhea not controlled by specific therapeutic means
  4. Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN. Note: At the PI's discretion, non-eligible patients can be re-screened after adequate medical therapy has been instituted.
  5. Patients with symptomatic cholelithiasis
  6. Patients who have congestive heart failure (NYHA Class III or IV), 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.
  7. Patients with congenital QTc syndrome, drug-induced prolonged QTc interval, or QTc measurement > 450 msec.
  8. Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, and/ or ALT or AST > 2.5 X ULN
  9. Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years.
  10. Patients with active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot).
  11. Patients with ANC <1.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L
  12. Patients who have any current or prior medical condition that, in the opinion of the Investigator, may interfere with the conduct of the study, the evaluation of its results, or the rigorous completion of the informed consent process.
  13. Female patients who are pregnant or lactating, or adults of childbearing potential who are not practicing a medically acceptable method of birth control. Female patients must use barrier contraception in addition to condom use in their partner. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards.
  14. Patients who have participated in any clinical investigation with an investigational drug (other than SOM230) within 1 month prior to study drug dosing.
  15. Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations (see section 6.1.1)
  16. Patients with a history of non-adherence to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813592

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Novartis
Investigators
Principal Investigator: Michael Glantz, MD University of Utah
  More Information

No publications provided

Responsible Party: Huntsman Cancer Institute ( Michael Glantz, MD )
Study ID Numbers: 26519
Study First Received: November 17, 2008
Last Updated: April 8, 2009
ClinicalTrials.gov Identifier: NCT00813592     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
meningioma
brain

Study placed in the following topic categories:
Meningeal Neoplasms
Meningioma
Central Nervous System Neoplasms
Hormones
Somatostatin
Nervous System Neoplasms
Recurrence

Additional relevant MeSH terms:
Meningeal Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningioma
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on August 28, 2009