Sunitinib to Treat Recurrent Brain Cancer
Stopped early · Phase 2
Conditions studied: Glioblastoma Multiforme, Malignant Gliomas, Anaplastic Gliomas
In brief
Background: One way tumors are able to grow is by forming new blood vessels that supply them with nutrients and oxygen. Sunitinib blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels. Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow. Objectives: To determine whether sunitinib can cause tumors to shrink or stabilize in patients with recurrent brain cancer. Eligibility: Patients 18 years of age or older with brain cancer whose disease has worsened after standard treatment with surgery, radiation. Design: Patients take a sunitinib pill once a day in 4-week treatment cycles. Treatment may continue as long as the tumor remains stable or decreases in size and the side effects of treatment are tolerated. Routine blood tests are done every 2 weeks during the first 8 weeks of treatment and then every 4 weeks after that. Magnetic resonance imaging (MRI) scans are done before starting treatment (at baseline) and at the end of every 4-week cycle to monitor tumor growth. Positron emission tomography (PET) scans are done at baseline and at the end of the first cycle. Neurological and physical examinations are done at baseline, at week 2 of treatment and at the end of every treatment cycle. Health-related quality of life is assessed every 4 weeks. Pregnancy tests, electrocardiograms and echocardiograms are repeated as needed.
Key facts
- Study ID
- NCT00923117
- Run by
- National Cancer Institute (NCI)
- People needed
- 87
- Starts
- 2008-06-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2015-09-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases are ineligible.
- Patients with a history of prior therapy directed against vascular endothelial growth factor (VEGF) (e.g. sorafenib, pazopanib, Zactima (ZD6474), AZD2171), with the exception of bevacizumab, will not be allowed to enroll.
- Concurrent use of other standard chemotherapeutics or investigative agents.
- Patients known to have a malignancy (other than their malignant glioma) that has required treatment in the last 12 months and/or are expected to require treatment in the next 12 months (except non-melanoma skin cancer or carcinoma in-situ in the cervix).
- Patients who have an active infection.
- Pregnant (positive pregnancy test) or nursing women. Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 3 months after the completion of sunitinib therapy.
- Concurrent anti-coagulation or anti-platelet medication (including aspirin, non-steroidal anti-inflammatory agents, cyclooxygenase -2 (COX-2) inhibitors).
- Serious or non-healing wound, ulcer or bone fracture
- History of any of the following within 6 months of study entry: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, stroke, myocardial infarction or unstable angina. Patients will not undergo diagnostic screening for any of these conditions.
- Invasive procedures defined as follows:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy
- Anticipation of need for major surgical procedures during the course of the study
- Core biopsy within 7 days prior to start of therapy
- Uncontrolled hypertension (greater than 150/100 mmHg) while on antihypertensive medications.
- New York Heart Association class II or greater congestive heart failure.
- Serious cardiac arrhythmia requiring medication.
- Evidence of bleeding diathesis, coagulopathy, or international normalized ratio (INR) greater than 1.5.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib.
- Patients receiving any enzyme inducing anti-epileptic drugs (EIAEDs) and other potent cytochrome P450 3A4 (CYP3A4) modulators (per Appendixes B and C) within two weeks prior to treatment start are ineligible.
- Baseline echocardiogram with ejection fraction less than 50% or greater than or equal to 20% decrease from a prior study
- corrected QT interval(QTc) interval greater than 500 msec on baseline electrocardiogram (EKG).
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sunitinib.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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