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

NCT00589784

Last updated date
Study Location
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
CNS Cancer, Meningioma, Intracranial Hemangiopericytoma, Hemangioblastoma, Neurofibromatosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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CNS Cancer, Meningioma, Intracranial Hemangiopericytoma, Hemangioblastoma, NeurofibromatosisPhase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
NCT00589784
  1. Boston, Massachusetts
  2. Basking Ridge, New Jersey
  3. Commack, New York
  4. New York, New York
  5. Pittsburg, Pennsylvania
  6. Charlottesville, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
Official Title  ICMJE Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • CNS Cancer
  • Meningioma
  • Intracranial Hemangiopericytoma
  • Hemangioblastoma
  • Neurofibromatosis
Intervention  ICMJE Drug: Sunitinib
The study drug will be administered on an outpatient basis. The starting dose will be 50 mg daily for 28 days (4 consecutive weeks) followed by 14 days off for patients not on CYP3A4 inducers or inhibitors. A cycle equals 42 days.
Other Names:
  • Patients on strong CYP3A4 inducers should start at a dose of 62.5 mg and those
  • on strong CYP3A4 inhibitors should start at a dose of 37.5 mg. The dose should
  • be taken once daily at approximately the same time each day.
  • Patients are required to have a drug rest period of at least 14 days after
  • each dosing period. The start of the next cycle may be delayed if additional
  • time is required for the patient to recover from sunitinib-associated toxicity
  • experienced during the previous cycle. An interruption in therapy of greater
  • than 28 days must be approved by the PI. Dosing can be modified after
  • discussion with the study investigator. The study investigator may implement
  • dose suspension or reduction in order to ensure patient safety. Patients will
  • be given a diary to take home to record their sunitinib dosing.
  • This will be brought back to the clinic following each cycle of treatment.
  • SU011248
Study Arms  ICMJE Experimental: Treatment
Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks, followed by a two-week rest period. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Imaging studies will be performed after every other cycle. Patients may continue on study as long as they are tolerating treatment and in the absence of disease progression.
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2009)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2008)
30
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00589784
Other Study ID Numbers  ICMJE 07-135
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Dana-Farber Cancer Institute
  • University of Virginia
  • University of Pittsburgh
  • Pfizer
Investigators  ICMJE
Principal Investigator:Thomas Kaley, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP