Expired Study
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Tampa, Florida 33612


We are asking patients to take part in this study because they have recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). The purposes of this study are: - To see if Sutent has any change on the patient and their cancer. - To see if Sutent will slow or stop the growth of their tumor. - To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved to treat patients with a gastrointestinal stromal tumor after the disease worsened while taking another medicine called imatinib mesylate or when imatinib mesylate cannot be taken. Sutent is also FDA approved to treat patients with advanced renal cell carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help patients with this disease live longer. Sutent will be administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Neurologic and neuroradiographic evaluations will be performed every 6 weeks to assess for response.

Study summary:

Patients with complete response (CR), partial response (PR), or stable disease (SD) will be treated for a maximum of 9 cycles [1 year] or until disease progression. For patients responding to treatment, continuation of therapy beyond 9 cycles is at the discretion of the investigator. At the beginning of each cycle, patients will be given Sutent capsules. They will take capsules once a day, with or without meals. The starting dose is 50 mg of Sutent for patients not on anticonvulsant drugs (AEDs) or on non-cytochrome P450 inducing AEDs [gabapentin, lamotrigine, topiramate; zonisamide, valproic acid, tiagabine, leviacetram]. Patients should be carefully monitored for toxicity. If patient requires more than two dose level modifications, then patient is removed from study. Patients will need to visit the clinic for physical and clinical tests (blood tests and an magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain) on Day 1. A nurse or doctor will ask how they are feeling, ask about any side effects that they may be having, and about any changes to the other medications they may be taking. Blood tests are required on day 21 (plus or minus 2 days) of each cycle, at the Moffitt lab or a local lab. During the study, patients will be followed for any side effects of the study drug. The dose of study drug may be reduced if side effects occur. If the side effects are bad enough, their doctor may temporarily stop the study drug, reduce the dose, or withdraw the study drug completely. Patients are seen after every cycle of therapy, i.e., 6 weeks and undergo neurological examination and MRI brain imaging. After cessation of protocol therapy, patients will continue to be followed for survival at 2-3 month intervals for up to three years from start of treatment. SCHEDULE OF EVENTS - PROTOCOL ACTIVITIES <14 Days Prior to Initial Study Treatment: - Neurological/Oncological History - Neurological Examination - Height/Weight/Body Surface Area - Performance Status - Quality of Life (QOL) FACT-L - Laboratory Studies; complete blood count (CBC), Differential, Platelets, prothrombin time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), Serum Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), Total Bilirubin, alkaline phosphatase (AlkPHs), Pregnancy Test, electrocardiogram (EKG) - Cranial MRI or CT with and without contrast - Multiple uptake gated acquisition (MUGA) Scan Day 1, At the Beginning of Each Treatment Cycle: - Adverse Event Assessment - Laboratory Studies; CBC, Differential, Platelets Every Cycle, Days 42-45 (within 3 days of next scheduled Sutent treatment): - Neurological/Oncological History - Neurological Examination - Height/Weight/Body Surface Area - Performance Status - QOL FACT-L - Laboratory Studies; Serum Creatinine, BUN, ALT, AST, LDH, Total Bilirubin, AlkPHs - Cranial MRI or CT with and without contrast - Survival At Off Study: - Performance Status - Cranial MRI or CT with and without contrast - Survival


Inclusion Criteria: - Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to NCI CTCAE Version 3.0 grade ≤1. - Adequate organ function as defined by the following criteria: - Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤3 x local laboratory upper limit of normal (ULN), or AST and ALT ≤3 x ULN if liver function abnormalities are due to underlying malignancy - Total serum bilirubin ≤1.5 x ULN - Absolute neutrophil count (ANC) ≥1500/µL - Platelets ≥100,000/µL - Hemoglobin ≥9.0 g/dL - Serum calcium ≤12.0 mg/dL - Serum creatinine ≤1.5 x ULN - Patients must have histologically or neuroradiographically recurrent anaplastic astrocytoma (AA) or glioblastoma (GBM). Must have had prior pathologic confirmation of primary tumor histology. - Must be ≥ 18 years old. - Must have a KPS ≥ 60% - Measurable disease per MacDonald criteria required using contrast enhanced cranial MR. - Life expectancy ≥ 12 weeks. - Must sign and date an IRB approved informed consent stating that he or she is aware of the neoplastic nature of the disease. Must willingly provide written consent after being informed of procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. - Willing and able to comply with scheduled visits, treatment plan, laboratory tests and accessible for follow-up. - Must have undergone surgery documenting tumor histology though repeat surgery at time of tumor recurrence is not mandatory. - Must have received prior external beam radiotherapy. - Patients may have received one or two prior salvage chemotherapy and may have received adjuvant chemotherapy following initial surgery. - May not have received prior stereotactic radiotherapy. - May have been treated with Gliadel at initial surgery only. Exclusion Criteria: - Major surgery or radiation therapy within 4 weeks of starting study treatment. - NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment. - History of or known spinal cord compression or carcinomatous meningitis, or evidence of leptomeningeal disease on screening CT or MRI scan. - Any of the following within 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 grade ≥2. - Prolonged QTc interval on baseline EKG. - Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy). - Pre-existing thyroid abnormality with thyroid function that cannot be maintained in 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. - Concomitant use of ketoconazole and other agents known to inhibit CYP3A4. - Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system. - Ongoing treatment with therapeutic doses of Coumadin (low dose up to 2 mg po daily for thrombo-prophylaxis is allowed). - Pregnancy or breastfeeding. Female subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. Female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of investigator would make subject inappropriate for entry into this study. - Patients having been treated with 3 or more salvage regimens. - Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix. - Mentally incapacitated patients or psychiatric illness that would prevent them from giving informed consent. - Poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within previous six months, or serious uncontrolled cardiac arrhythmia. - Known to be HIV positive or to have an AIDS-related illness. - Patients with an active infection that is not adequately controlled with antibiotics. - Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. - Known sensitivity to any of the products to be administered during treatment. - Currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.



Primary Contact:

Principal Investigator
Edward Pan, M.D.
H. Lee Moffitt Cancer Center and Research Institute

Backup Contact:


Location Contact:

Tampa, Florida 33612
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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