Sunitinib for Advanced Thymus Cancer Following Earlier Treatment

• INCLUSION CRITERIA:

3.1.1 Histological confirmation of thymoma (Group 1 only) or thymic carcinoma by the pathology department/Center for Cancer Research (CCR)/national Cancer Institute (NCI) or the pathology department of participating institutions.

3.1.2 At least one prior line of platinum-based chemotherapy or patient must have refused cytotoxic chemotherapy. Progressive disease must be documented prior to study entry.

3.1.3 Patients must not have received chemotherapy, radiation therapy, or undergone major surgery within 4 weeks prior to enrollment.

3.1.4 Patients must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

3.1.5 Age greater than or equal to 18 years.

3.1.6 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky > 50 percent)

3.1.7 Life expectancy of greater than 3 months.

3.1.8 Patients must have normal organ and marrow function as defined below:

• hemoglobin greater than or equal to 9 g/dL
• leukocytes greater than or equal to 3,000/mcL
• absolute neutrophil count greater than or equal to 1,200/mcL
• platelets greater than or equal to 100,000/mcL
• total bilirubin within normal institutional limits
• serum calcium less than or equal to 12.0 mg/dL
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT)/alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 times institutional upper limit of normal
• creatinine within normal institutional limits

OR

• creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
• If subjects have liver metastases, both ALT and AST must be less than or equal to 5 times upper limit of normal (ULN).
• Patients must have corrected QT Interval (QTc) < 500 msec

3.1.9 Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time test (APTT) less than or equal to 1.5 times upper limit of normal (ULN), unless the abnormality can be explained by the presence of lupus anticoagulant or if these values are in the therapeutic range for a patient on low molecular weight heparin.

3.1.10 The following groups of patients are eligible provided they have New York Heart Association Class II (NYHA) cardiac function on baseline echocardiogram (ECHO)/multi-gated acquisition scan (MUGA):

• those with a history of Class II heart failure who are asymptomatic on treatment
• those with prior anthracycline exposure
• those who have received central thoracic radiation that included the heart in the radiotherapy port.

3.1.11 Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility. Initiation or adjustment of BP medication is permitted prior to study entry provided that the average of three BP readings at a visit prior to enrollment is less than 140/90 mmHg.

3.1.12 Absence of brain metastases as confirmed by imaging of the brain by magnetic resonance imaging (MRI) or computed tomography (CT) brain with contrast performed at baseline screening

3.1.13 The effects of sunitinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because anti-angiogenic agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of sunitinib administration.

3.1.14 Ability t