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Home > "S" Clinical Trials Conditions > STI571 to Treat Malignant Brain Tumors  STI571 to Treat Malignant Brain Tumors
STI571 to Treat Malignant Brain Tumors
For Condition: Glioma,Gliosarcoma,Astrocytoma,Meningioma,Oligodendroglioma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study has two phases. Phase I will determine the highest dose of the experimental drug STI571 that can be given to patients with brain tumors without causing severe side effects. Phase II will evaluate whether this drug can prevent tumor growth in these patients. STI571 has slowed the growth of cancerous brain tumors in animals and has killed cancerous blood cells in patients with leukemia. The drug may work by 1) blocking signals that stimulate cells to grow, and 2) inhibiting the formation of new blood vessels that carry nourishment to the tumor. Patients with recurrent brain tumors whose disease does not respond to standard treatment may be eligible for this study. Both patients who are taking anti-seizure medicines and those who are not will be recruited for the study, since these medicines may influence the way the body handles, or metabolizes, STI571. Candidates must have evidence by magnetic resonance imaging (MRI) or computed tomography (CT) that their tumor is growing. Patients enrolled in the study will undergo a repeat MRI and will have physical and neurological examinations and blood tests within 2 weeks of starting treatment. Participants in both study phases will take STI571 capsules once or twice a day, depending on the dose. This may consist of a total of 4 to 12 capsules per day. The first group of patients in phase I will be given a low dose of STI571. The dose will be increased with subsequent groups of patients as long as the drug is well tolerated. All patients will have physical and neurologic examinations every 4 weeks for as long as treatment continues. Routine blood tests will be taken at regular intervals throughout the course of treatment, as will special blood tests to measure blood levels of STI571, to analyze serum proteins, and to test for substances that stimulate growth of new blood vessels. The intervals of these tests vary for participants in the two different study phases. After the 8th week of treatment, patients in both study phases will have a repeat MRI or CT scan to assess treatment response. Patients whose tumor has increased by less than 50%, remained stable or shrunk may continue to receive STI571. Patients whose tumor has doubled in size or who experience unacceptable drug side effects will be taken off the study. Patients may be requested to undergo additional tests, including dynamic MR with spectroscopy and positron emission tomography (PET) scanning, which can help distinguish live tumor from dying tumor. The procedure for MR with spectroscopy is identical to MRI and will be done at the same time as the standard MRI scan. The procedure for PET is similar to that for CT, but involves injection of a small amount of radioactive tracer material. Patients may continue treatment until STI571 no longer shows benefit or unacceptable side effects appear. Continuation of treatment will be reassessed after 1 year, for those still taking the drug at that time.
Details: There is increasing evidence that tumor growth is angiogenesis-dependent. PDGF is one of the growth factors that may have a role in the angiogenesis associated with malignant gliomas. Inhibition of PDGF with STI571 may also produce an antitumor effect through an anti-angiogenic mechanism.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with histologically proven intracranial malignant glioma will be eligible for this protocol. Malignant glioma include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified), gliosarcoma, and benign or malignant meningiomas. For patients on the phase I portion of the study only, patients will also be eligible if they have a recurrent or an unresectable meningioma or if the original histology was low grade and a subsequent diagnosis of a malignant glioma is made. For patients on the phase II portion of the study, patients with recurrent malignant glioma are eligible. Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI or CT scan performed within 14 days prior to registration and/or documented recurrence by tumor resection. The baseline on-study MRI/CT should be performed within 14 days of registration and on a steroid dosage that has been stable for at least 5-7 days. If the steroid dose is increased between the date of imaging and the initiation of STI571, a new baseline MRI/CT is required on stable steroids for 5-7 days. The same type of scan, e.g., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: -They have recovered from the effects of surgery; -Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. Only patients who are eligible for participation in the phase II component of the study may be enrolled in a pre-operative study to evaluate biological and/or tissue correlates; -To best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively; -The baseline on-study MRI/CT should be performed within 14 days of registration and on a steroid dosage that has been stable for at least 5-7 days. If the steroid dose is increased between the date of imaging and the initiation of STI571, a new baseline MRI/CT is required on stable steroids for 5-7 days. The same type of scan, e.g., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement. Patient must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry. Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium scanning, MR spectroscopy or surgical documentation of disease. Prior therapy (including gliadel wafers): For the phase I component, patients with AA, AO, AMO must have had treatment with one prior chemotherapy regimen. Patients with GBM, gliosarcoma or meningioma are not required to have prior treatment with chemotherapy. All patients may have had treatment for no more than three prior relapses; For the phase II component, patients may have had treatment for no more than 2 prior relapses. Patients are not required to have had prior treatment with chemotherapy. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must be registered in the North American Brain Tumor Consortium Data Management Center (NABTC DMC) database prior to treatment with study drug. 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: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week from non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.. (radiosensitizers do not count). Patients who begin or stop drugs that affect hepatic metabolism should not enter the study for at least two weeks to allow the effects on hepatic enzymes to recover. Patients must have adequate bone marrow function (ANC greater than or equal to 1,500/mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 gm%) and tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. Patient must have adequate liver function (SGOT and bilirubin less than 2 times the upper limit of normal) tests must be performed within 14 days prior to registration. Patient must have adequate renal function (creatinine less than 1.5 mg/dL and creatinine clearance greater than or equal to 60 cc/min) before starting therapy and tests must be performed within 14 days prior to registration. Patient's PT, INR and PT must be less than 1.5 times institutional upper limit of normal and tests must be performed within 14 days prior to registration. EXCLUSION CRITERIA: Patients with significant cardiac, hepatic, gastrointestinal, renal, or psychiatric disease are ineligible. Patients with deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of entry are not eligible. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise that patient's ability to tolerate this therapy. 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 tis study will be based on race. Patients of childbearing potential must not become pregnant and must not father a child during treatment with STI571 and for up to 6 months after completing study drug. Barrier contraception must be employed while on study treatment. Patients must not have serious active infection. Patients must not have disease that will obscure toxicity or dangerously alter drug metabolism. Patients must not have serious intercurrent medical illness. Patients must not have concurrent use of other investigational agents. Patients must not be on warfarin. Patients must not have a prior history of intracranial hemorrhage. Patients must not have any bleeding disorders. The patient's PT, INR and PTT must be less than or equal to 1.5 times institutional upper limit of normal and tests must be performed within 14 days prior to registration.
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010243; 01-C-0243
Study Start Date: August 24, 2001
Record last reviewed: May 3, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023179
Other Glioma Studies:
1. STI571 to Treat Malignant Brain Tumors
2. Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
3. SU5416 to Treat Recurrent Brain Tumors
4. Evaluation of Factors in Human Brain Tumors
5. A Phase II Trial of Intravenous Cereport ® (Registered Trademark) (RMP-7) and Carboplatin in Childhood Brain Tumors
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STI571 to Treat Malignant Brain Tumors
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