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SU5416 to Treat Recurrent Brain Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on SU5416 to Treat Recurrent Brain Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. SU5416 to Treat Recurrent Brain Tumors Clinical research trials and SU5416 to Treat Recurrent Brain Tumors medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including SU5416 to Treat Recurrent Brain Tumors. SU5416 to Treat Recurrent Brain Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a SU5416 to Treat Recurrent Brain Tumors clinical trial. Participants oftentimes recieve the finest healthcare available for their SU5416 to Treat Recurrent Brain Tumors condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SU5416 to Treat Recurrent Brain Tumors  SU5416 to Treat Recurrent Brain Tumors
SU5416 to Treat Recurrent Brain Tumors
For Condition: Glioma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a phase I/II study of the experimental drug SU5416 as an agent for controlling the growth of brain tumors. SU5416 inhibits the formation of new blood vessels, which tumors need in order to receive nourishment and survive. Slowing or preventing the development of these blood vessels may also slow the growth of the tumors. Phase I will determine the highest dose of the drug that can safely be given to patients with brain tumors and see whether the highest tolerated dose of the drug is different in patients taking anti-seizure medicines. Phase II will examine the effect of the drug on brain tumor growth. Patients 18 years of age and older with recurrent brain tumors that cannot be successfully treated with standard therapies may be eligible for this study. Patients who are taking anti-seizure medication as well as those who are not may enroll. Participants must have a magnetic resonance imaging (MRI) scan, physical and neurologic examination and blood tests done within 2 weeks of beginning treatment. Patients enrolled in the study will then receive SU5416 in 4-week cycles, infused through a catheter (a thin, flexible tube) placed into a large vein in the arm, neck or above the collarbone. The infusions will be given twice a week for 4 consecutive weeks (one cycle). Routine blood tests will be done periodically throughout the study. During the first infusion a special blood test will be done to measure levels of the drug at various times during and after the infusion. Blood will be collected just before the infusion begins, 30 minutes into the infusion, and at 1/4, 1/2, 1, 2, 3, 4, 6, 8, and 24 hours after the infusion. Additional blood and urine samples will be collected every 4 weeks to test for substances that stimulate growth of new blood vessels. Patients will have physical and neurologic examinations every 4 weeks and a MRI at week 8 of the study and again at 6 months. Treatment will continue until there is evidence that the SU5416 is not controlling the tumor or severe side effects dictate that treatment should end. For patients still taking the drug at the end of 1 year, the decision to continue will be re-evaluated at that time.
Details: SU5416 is a small molecule drug developed by Sugen. It selectively inhibits the tyrosine kinase activity of Flk-1, a receptor tyrosine kinase expressed on vascular endothelial cells. VEGF is the ligand for Flk-1. This agent can inhibit tumor growth in vivo in animal tumor models. In humans, SU5416 is rapidly cleared from plasma by metabolism, and the rate of metabolism increases after multiple doses. The dose-limiting toxicity in a prior Phase I trial was nausea, headache, and vomiting at a dose of 190 mg/m(2). The trial is designed to define the MTD, toxicities, and PK of SU5416 in patients with brain tumors divided into two groups based on whether they are receiving anticonvulsants. The activity of SU5416 will be assessed in this population using time to progression as the endpoint. Surrogate endpoints for angiogenic activity in vivo are also being tested. The targeted patient population for this trial is adults with high-grade gliomas with recurrence or progression. Patients are stratified for the Phase I trial based on whether they are receiving anticonvulsants. The schedule of administration is days 1 and 4 of each week for 4 weeks. Cycles are 4 weeks so drug administration is continuous. There are six planned dose levels from 85 to 340 mg/m(2). The Phase I portion of the trial follows a standard Phase I trial design (three patients per dose level) with standard definitions of DLT and MTD. The Phase II trial will measure the percentage of patients who are progression-free and alive at 6 months. The Phase II portion of the trial is powered to detect a 20 percent increase in PFS at 6 months with 48 patients (32 with GBM).
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically proven supratentorial malignant primary gliomas, or brain and spinal meningiomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified), and benign or malignant meningiomas. Patients must have shown unequivocal evidence for tumor recurrence or progression by CT or (preferably) MRI. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the following conditions apply: a) they have recovered from the effects of surgery; b) for assessing disease in most cases, two imaging studies will be necessary: an early post-op MRI/CT, ideally within 48 hours but no later than 96 hours post-op, and then a baseline, on-study MRI/CT as below. Occasionally, the pattern of enhancement on a single imaging study performed 4-6 weeks post-op may by itself be strongly suggestive of tumor rather than (or in addition to) post-op inflammatory enhancement. In such cases, the on-study films will be reviewed by the study chairperson (Howard A. Fine, M.D.), who will make the final determination on the patient's eligibility; and, c) patients with no measurable or evaluable disease on post-op imaging may be included in the study, but their 6-month progression-free survival will be evaluated separately from the main cohort of patients. Patient must have failed prior radiation therapy. For the phase I portion of the trial (patients with gliomas or meningiomas), patients may have had only two prior chemotherapy regimens for recurrent disease. For the phase II portion of the trial (only patients with gliomas), patients must have completed radiation therapy at least two months prior to enrollment and patients may have had only one prior chemotherapeutic regimen for recurrent tumor. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must be greater than or equal to 18 years old, and with a life expectancy greater than 8 weeks. Patients must have a Karnofsky performance status of greater than or equal to 60. Patients must have recovered from the toxic effects of prior therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 3 weeks for non-cytotoxic agents, e.g., interferon, tamoxifen, etc. Patients must have adequate bone marrow function (WBC greater than or equal to 2,300/l, platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 8 gm%), adequate liver function (SGOT less than 2.5 times the upper limit of normal and normal bilirubin), and adequate renal function (creatinine less than 1.5 mg/dL or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. The baseline on-study MRI/CT should be performed within 14 days of initiating SU5416 and on a steroid dosage that has been stable for 5 days. If the steroid dose is increased after the imaging and before (or in conjunction with) the start of SU5416, a new baseline MRI/CT is required at the new steroid dose. The same type of scan, i.e., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement. All patients must have a prestudy contrast MRI or contrast CT of the brain within 14 days prior to registration. The same type of scan, i.e., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement. EXCLUSION CRITERIA: Patients with significant active, hepatic, renal, or psychiatric disease are ineligible. Patients with uncompensated coronary artery disease on electrocardiogram or physical examination, or with a history of myocardial infarction or severe/unstable angina in the past 6 months are not eligible. Patients with diabetes mellitus with severe peripheral vascular disease and patients who have had a deep venous or arterial thrombosis (including pulmonary embolism) within 3 months of entry are not eligible. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with SU5416. No concurrent use of other investigational agents. Patients must not have: Serious active infection; Disease that will obscure toxicity or dangerously alter drug metabolism; Serious intercurrent medical illness. Patients must be capable of having some type of "long line" venous access devise placed such as a PICC line, Mediport, or central venous catheter.
Total Enrollment: 78
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000173; 00-C-0173
Study Start Date: July 12, 2000
Record last reviewed: February 6, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006067
Other Glioma Studies:
1. STI571 to Treat Malignant Brain Tumors
2. Phase I Trial of Thalidomide Analog CC-5013 in Patients with Gliomas
3. Evaluation of Factors in Human Brain Tumors
4. Phase I Trial and Pharmacokinetic Study of TLC D-99 in Pediatric Patients with Refractory Solid Tumors
5. A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas
Related Studies:
Other Glioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
SU5416 to Treat Recurrent Brain Tumors
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