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Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: CNS Cancer; Meningioma; Intracranial Hemangiopericytoma; Hemangioblastoma; Neurofibromatosis

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Thomas Kaley, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to find out what effects, good and/or bad, sunitinib has on patients and their tumors. At this time, no drugs are routinely used to treat meningioma, hemangioblastoma or hemangiopericytoma. Only surgery and radiation therapy are known to be useful. Sunitinib is a drug approved for advanced kidney cancer. Sunitinib is also being studied for other tumors. It may be useful in the treatment of brain tumors because it can prevent formation of new blood vessels that allow tumor cells to survive and grow.

Clinical Details

Official title: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate the activity of sunitinib in patients with recurrent meningiomas as measured by 6-month progression-free survival.

Secondary outcome:

To describe the response rate, median-time-to-progression and overall survival in this patient population; To evaluate the safety of sunitinib in patients with recurrent meningiomas.

To evaluate the safety of sunitinib in patients with recurrent meningiomas.

To develop exploratory data correlating response to the molecular phenotype of the tumor.

To develop exploratory data correlating serum angiogenic peptides and Dynamic Contrast Enhanced (DCE)-MRI with outcomes.

Detailed description: This is a phase II study of Sunitinib in patients with recurrent or inoperable meningiomas. An exploratory study will be performed for patients with recurrent hemangiopericytoma or hemangioblastoma. There will be approximately 50 patients enrolled on this study (40 meningiomas and 10 hemangiopericytomas/hemangioblastomas). The treatment plan is to use daily SU11248 at a dose of 50 mg, using the established schedule of 4 weeks of treatment followed by two weeks of rest period, forming a six-week treatment cycle. A medical professional will see each patient at least every six weeks while on the medication for toxicity assessment and physical examination. Extent of disease evaluations will occur at baseline, two weeks, twelve weeks, 24 weeks, and every twelve weeks thereafter. These evaluations will include MRI of the brain (or CT head if a patient cannot undergo MRI) and MR perfusion.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically proven recurrent meningioma or intracranial hemangiopericytoma or

hemangioblastoma. This includes benign, atypical, or malignant meningioma; patients with neurofibromatosis type 1 or 2 may participate.

- Patients with classic radiographic picture of meningioma may also enroll if not

surgically accessible. In this instance the patient must be reviewed at multi-disciplinary brain tumor conference including neurosurgery and neuroradiology to determine that the patient is appropriate for this study.

- Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is

contraindicated). The scan must be performed within 14 days of registration.

- Steroids dosing - malignant meningiomas must be on stable dose for at least 5 days

prior to baseline imaging. For patients with benign or atypical meningiomas, stable steroid doses are not required.

- Recent resection for recurrent tumor - patients will be eligible as long as they have

recovered from the effects of surgery and have residual disease that can be evaluated. To best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively. If the 96 hour scan is more than 14 days before registration, it should be repeated. Because Sunitinib is a VEGF inhibitor that can carry many risks including thrombocytopenia, bleeding, hypertension, and stroke, patients must wait at least 14 days after surgery, without complication, before they may initiate study drug.

- Prior radiation therapy - patients may have been treated with standard external beam

radiation, interstitial brachytherapy, or radiosurgery in any combination. An interval of ≥ 4 weeks (28 days) must have elapsed from the completion of radiation therapy to study entry and there must be subsequent evidence of tumor progression. Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR spectroscopy or surgical documentation of disease.

- Patients who have not had prior surgery or radiotherapy for their meningioma will be

reviewed at multi-disciplinary brain tumor conference including neurosurgery and radiation oncology to determine that the patient is appropriate for this study.

- Prior therapy: There is no limitation on the number of prior surgeries, radiation

therapy, radiosurgery treatments, or chemotherapy.

- All patients must sign an informed consent indicating that they are aware of the

investigational nature of the study. Patients must sign an authorization for the release of their protected health information.

- Age ≥ 18 years old

- Karnofsky performance status ≥ 60%.

- ≥ 4 weeks since prior RT, stereotactic radiosurgery, or chemotherapy.

- Required Initial Laboratory Values (within 14 days of registration):

Absolute neutrophil count (ANC) ≥ 1,000/mm3

- Platelets ≥ 100,000/mm3

- hemoglobin ≥ 8gm/dl

- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT])

and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2. 5 x local laboratory upper limit of normal (ULN)

- Creatinine ≤ 2. 0 mg/dl

- PT, INR, and PTT ≤ 1. 5 times institutional upper limits of normal

- Total serum bilirubin ≤ 1. 5 - Patients with a history of NF may have other stable CNS

tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months. Exclusion Criteria:

- Patients with the history of any other cancer (except non-melanoma skin cancer or

carcinoma in-situ of the cervix, unless in complete remission and off all therapy for the disease for a minimum of 3 years) are ineligible.

- Any prior TKI therapy (SU011248, Sorafenib, Semaxinib, Axitinib)

- Concomitant use of any other investigational drugs

- Concomitant use of enzyme-inducing anti-epileptic drugs.

- Concomitant use of St John's Wort.

- Any of the following within the 6 months prior to study drug administration:

myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.

- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3. 0 grade ≥ 2.

- Prolonged QTc interval on baseline EKG (>450 msec for males and >470 msec for

females).

- Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy). Patients

are excluded if they have an elevated diastolic, an elevated systolic, or both.

- History of intracranial hemorrhage.

- Pre-existing thyroid abnormality, with thyroid function tests that cannot be

maintained in the normal range with medication.

- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome

(AIDS)-related illness or other active infection.

- Concurrent treatment on another clinical trial. Supportive care trials or

non-treatment trials, e. g. QOL, are allowed.

- Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg

daily for thromboembolic prophylaxis is allowed).

- Pregnancy or breast-feeding. Patients must be surgically sterile, postmenopausal, or

agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception. Women of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to registration.

Locations and Contacts

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack, Commack, New York 11725, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States

University of Pittsburgh Medical Center, Pittsburg, Pennsylvania, United States

University of Virginia Health Science Center, Charlottesville, Virginia 22908, United States

Additional Information

Memorial Sloan-Kettering web site

Starting date: October 2007
Last updated: October 29, 2014

Page last updated: August 23, 2015

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