| Criteria: |
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Inclusion Criteria:
- Histologically confirmed solid tumor or malignant glioblastoma multiforme meeting >=
1 of the following criteria:
- Disease refractory to standard therapy
- No standard therapy exists
- Sunitinib malate monotherapy would be appropriate management
- Measurable disease is not required
- Previously treated brain metastases or primary brain neoplasms allowed provided
patient is not receiving concurrent corticosteroids
- Karnofsky performance status 70-100%
- Absolute neutrophil count (ANC) >= 1,500/μL
- White blood cell count (WBC) >= 3,000/μL
- Platelet count >= 100,000/μL
- Hemoglobin >= 9 g/dL
- Total bilirubin normal (unless due to documented Gilbert syndrome)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper
limit of normal (ULN) (< 5 times ULN in the presence of liver metastases)
- Creatinine normal OR creatinine clearance >= 60 mL/min
- Serum calcium =< 12.0 mg/dL
- QTc < 500 msec
- Patients with any of the following are allowed provided they have New York Heart
Association (NYHA) class I-II cardiac function and undergo a baseline echocardiogram
(ECHO)/multiple gated acquisition (MUGA):
- History of class II heart failure and asymptomatic on treatment
- Prior anthracycline exposure
- Previously treated with central thoracic radiotherapy that included the heart in
the radiotherapy port
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to sunitinib malate
- No concurrent uncontrolled illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness and/or social situation that would limit compliance with
study requirements
- No pre-existing thyroid abnormality for which thyroid function cannot be maintained
in the normal range with medication
- No documented thrombosis (pulmonary embolism or deep vein thrombosis) within the past
6 months
- No known coagulopathy or thrombophilia
- No proven gastric or duodenal ulcer or clinically significant gastrointestinal (GI)
blood loss within the past 6 weeks
- No history of central nervous system (CNS) hemorrhage
- No life-threatening bleeding diathesis within the past 6 months
- No history of serious ventricular arrhythmia (i.e., ventricular fibrillation or
ventricular tachycardia >= 3 beats in a row) or other significant electrocardiogram
(ECG) abnormalities
- No poorly controlled hypertension (i.e., systolic blood pressure (BP) >= 150 mm Hg or
diastolic BP >= 100 mm Hg)
- No condition that would impair the ability to swallow and retain sunitinib malate
tablets, including any of the following:
- GI tract disease resulting in an inability to take oral medications or a
requirement for IV alimentation
- Prior surgical procedures affecting absorption
- Active peptic ulcer disease
- No gastrostomy, jejunostomy, or other forms of enteral tube feeding modalities
- None of the following conditions:
- Serious or non-healing wound or ulcer
- Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28
days
- Cerebrovascular accident or transient ischemic attack within the past 12 months
- Myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic
congestive heart failure, or coronary/peripheral artery bypass graft or stenting
within the past 12 months
- NYHA class III or IV heart failure
- Radiographically or physiologically diagnosed usual interstitial pneumonitis
(UIP) or non-specific interstitial pneumonitis (NSIP)
- No bone fracture within the past 12 months
- No other concurrent anticancer agents or therapies
- More than 4 weeks since prior radiotherapy or systemic antineoplastic therapy (6
weeks for nitrosoureas, mitomycin C, or bevacizumab) and recovered
- More than 2 weeks since prior hormone replacement therapy or hormonal contraceptives
- More than 1 month since prior surgery
- At least 7 days since prior and no concurrent CYP3A4 inhibitors
- At least 12 days since prior and no concurrent CYP3A4 inducers
- Prior luteinizing hormone-releasing hormone agonists for hormone-refractory prostate
cancer allowed
- Prior antiangiogenic agents (e.g., sorafenib, pazopanib, AZD2171 [cediranib maleate],
PTK787 [vatalanib], or VEGF Trap [ziv-aflibercept]) allowed provided there is no
disease progression
- No prior cilengitide or sunitinib malate
- No prior bevacizumab
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for human immunodeficiency virus
(HIV)-positive patients
- No concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine,
procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone,
indapamide, or flecainide)
- No concurrent palliative radiotherapy
- No other concurrent chemotherapy or biologic agents
- No concurrent medications that may cause QTc prolongation
- No concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g.,
warfarin)
- Up to 2 mg of daily warfarin for the prophylaxis of thrombosis allowed
- Low-molecular weight heparin allowed provided prothrombin time
(PT)/international normalized ratio (INR) =< 1.5
- No concurrent grapefruit juice
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