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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00589784
• Date of registration: 26/12/2007
• Prospective Registration: No
• Primary sponsor: Memorial Sloan Kettering Cancer Center
• Public title: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
• Scientific title: Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
• Date of first enrolment: October 2007
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00589784
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Thomas Kaley, MD
• Affiliation: Memorial Sloan Kettering Cancer Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

CNS Cancer

Meningioma

Neurofibromatosis

Hemangioblastoma

Intracranial Hemangiopericytoma

Intervention(s)

Drug: Sunitinib

Primary Outcome(s)

Overall Objective Response [Time Frame: 1.5 years]

Secondary ID(s)

07-135

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pittsburgh

Dana-Farber Cancer Institute

Pfizer

University of Virginia

Results

• Results available: Yes
• Date Posted: 25/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00589784