CNS CancerPhase 2NCT00589784
Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
A Phase 2 study testing Sunitinib in people with CNS Cancer and Meningioma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Cancer, Meningioma, Intracranial Hemangiopericytoma
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2007to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Virginia Health Science Center
Charlottesville, Virginia, 22908
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
About this study
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.
Read the 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.
- Conditions
- CNS Cancer, Meningioma, Intracranial Hemangiopericytoma, Hemangioblastoma, Neurofibromatosis
- Being tested
- Sunitinib
- Keywords
- Sunitinib, Brain Cancer, CNS Cancer, meningioma, intracranial hemangiopericytoma, hemangioblastoma, malignant meningioma, neurofibromatosis, neurofibromatosis type 1, neurofibromatosis type 2, 07-135
- Medical subject headings
- Central Nervous System Neoplasms, Meningioma, Hemangioblastoma, Neurofibromatoses, Brain Neoplasms, Neurofibromatosis 1, Neurofibromatosis 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response
Determine the overall objective response
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CNS CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kaley, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589784
- Sponsor's protocol ID
- 07-135
- Status last verified
- Dec 2015
- First submitted
- 26 Dec 2007
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
- ClinicalTrials.gov ID
- NCT00589784
- Acronym / sponsor ID
- 07-135
- Conditions
- CNS Cancer, Meningioma, Intracranial Hemangiopericytoma, Hemangioblastoma, Neurofibromatosis
- Keywords
- Sunitinib, Brain Cancer, CNS Cancer, meningioma, intracranial hemangiopericytoma, hemangioblastoma, malignant meningioma, neurofibromatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of Virginia, University of Pittsburgh, Pfizer
- Study start
- Oct 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: SunitinibSunitinib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunitinibAlso: 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 afterThe 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. | Drug | Treatment |
Primary outcome
Overall Objective Response
Time frame: 1.5 years
Determine the overall objective response
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kaley, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with CNS Cancer and Meningioma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Objective Response (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2016.