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Home > "S" Clinical Trials Conditions > ST1571 to Treat Patients with Recurrent Meningiomas  ST1571 to Treat Patients with Recurrent Meningiomas
ST1571 to Treat Patients with Recurrent Meningiomas
For Condition: Meningioma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of the experimental drug ST1571 in treating patients with recurrent meningiomas (a type of benign brain tumor). Genetic abnormalities in meningioma cells may lead to overproduction of certain growth factors and their receptors, resulting in tumor growth. One growth factor that is often excessive in meningioma is platelet-derived growth factor (PDGF), and it may be an important contributor to the growth of the tumor. ST1571 blocks the receptor for PDGF and may prevent it from stimulating tumor growth. Patients 18 years of age and older diagnosed with recurrent meningioma may be eligible for this study. Candidates will be screened with a physical and neurological examination and blood tests. Participants will take ST1571 by mouth once or twice a day, depending on the dose. For the first 3 months of treatment, patients will weigh themselves every day to look for weight gain as a result of fluid retention. In addition, they will undergo the following procedures. - Physical and neurological examinations every 4 weeks for the duration of treatment with ST1571. - Routine blood tests once a week for the first 4 weeks and then every 2 weeks. - Blood tests as follows: a. Before beginning treatment - to study genetic abnormalities in the tumor. b. On the eighth day of the first and third treatment cycles - to measure blood levels of ST1571. Two teaspoons of blood will be drawn before the first dose of ST1571 and then 1, 2, 3, 4, and 24 hours after the dose and again 1 week after the dose. c. On the first day of treatment cycles 2, 3, and 4 before the first dose of drug. d. Once every 4 weeks - to test for substances that stimulate the growth of new blood vessels. - Magnetic resonance imaging (MRI) or computerized tomography (CT) scans after 8 weeks of treatment to assess tumor response. If at that time there is no change in tumor size or if the tumor has shrunk, treatment will continue for another 8-week cycle. MRI uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. For the scan, the patient lies on a table in a narrow cylinder (the scanner) and must lie still for up to a few minutes at a time. CT allows organs to be viewed in small sections and in three dimensions. The patient lies in a doughnut-shaped machine for the procedure. Patients may also be asked to undergo the following procedures: - MR with spectroscopy - to help distinguish live tumor from dying tumor. This is similar to MRI and is done at the same time as the standard MRI scan. - Positron emission tomography (PET) scan. This test is similar to a CT scan, but a small amount of radioactive material is injected into a vein before the scan is performed - In patients who require an operation to remove a tumor or reduce its mass, some of the tumor specimen may be sent for special tests to determine the activity of ST1571 in the tumor. Patients will continue treatment until the ST1571 is no longer beneficial or side effects become too severe. After 1 year on the drug, the patient and doctor will decide whether to continue treatment. After stopping treatment, patients will be followed every 3 months to check their health status.
Details: No Precis
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: ELIGIBILITY CRITERIA : Patients with histologically proven recurrent meningioma will be eligible for this protocol. This may include patients with benign meningioma, malignant meningioma, or atypical meningiomas, who may or may not have neurofibromatosis type 1 or 2 (NF-1 or NF-2). Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI or CT scan. The scan should be performed within 21 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. Patients with malignant meningiomas should be on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required. For patients with benign or atypical meningiomas, stable steroid doses are not required for the baseline scan. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: a) They have recovered from the effects of surgery. b) Evaluable residual disease following resection of recurrent tumor is required for eligibility into the study. 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 at least 4 weeks post-operatively, within 21 days of registration. If the 96 hour scan is more than 21 days before registration, the scan needs to be repeated. For patients with benign or atypical meningiomas, stable steroid doses are not required for the baseline scan. For patients with malignant meningiomas the steroid dosage should be stable for at least 5 days prior to the scan. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days. All groups of patients in the study may be eligible for examination of tumor specimens: Patients with recurrent meningioma who require surgical debulking are eligible for the trial. These patients will be treated for 7 days with STI571 prior to undergoing surgery. The drug will be discontinued after surgery until the patient has recovered. STI571 may be resumed as early as 14 days after surgery if there are no contraindications but no later than 28 days. For phase II patients in the preoperative component, only a scan showing progression is required. For this scan only, stable steroids are not required. Following surgery, a scan should be done no later than 96 hours or at least 4 weeks from surgery, within 21 days of initiation of treatment. If the 96 hour scan is more than 21 days before initiation of treatment, the scan needs to be repeated. For patients with benign or atypical meningiomas, stable steroid doses are not required for the baseline scan. For patients with malignant meningiomas the steroid dosage should be stable for at least 5 days prior to the scan. If the steroid dose is increased between the date of imaging and initiation of treatment, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days. Prior radiation therapy is not mandated. Patients may have had treatment with radiation which could include standard external beam radiation, interstitial brachytherapy or gamma-knife radiosurgery in any combination. If radiation therapy was used, there must be an interval of > 4 weeks from the completion of radiation therapy to study entry and there must be subsequent evidence of tumor progression documented. Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery to the target lesion must have confirmation of true progressive disease rather than radiation necrosis based on either PET or thallium scanning, MR spectroscopy or surgical documentation of disease. Prior therapy: There is no limitation on the number of prior surgeries, radiation therapy or radiosurgery treatments or 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 > 18years old, and with a life expectancy > 8 weeks. Patients must have a Karnofsky performance status of > 60. Patients must have recovered from the toxic effects of prior therapy: 4 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy, 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from hydroxyurea or procarbazine administration, and 1 week from non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc (radiosensitizers do not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair. Patients must have adequate bone marrow function (ANC > 2,000/mm3, platelet count of > 120,000/mm3, and hemoglobin > 10 gm/dl). The tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. Patients must have adequate liver function (SGOT and bilirubin < 2 times the upper limit of normal). The tests must be performed within 14 days prior to registration. Patients who begin or stop drugs that affect hepatic metabolism (see Appendix 18.4) should not enter the study for at least two weeks to allow the effects on hepatic enzymes to recover. Patients must have adequate renal function (creatinine < 1.5 mg/dL and/or creatinine clearance > 60 cc/min [either measured or estimated]) before starting treatment. The tests must be performed within 14 days prior to registration. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy. Patients with deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of entry are NOT eligible. Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if those lesions have been stable in size for the preceding 6 months. 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. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. 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 of childbearing potential must not become pregnant/breast feeding and must not father a child during treatment with STI571 and for up to 3 months after completing study drug. Patients must agree to the use of barrier contraception while on study treatment. Women of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to registration. Patients must not be pregnant because animal studies show that STI571 is teratogenic. Patients must not have serious active infection or intercurrent medical illness. Patients must not have disease that will obscure toxicity or dangerously alter drug metabolism. Patient must not have concurrent use of other investigational agents. Patients must not be on warfarin (because of a potential interaction between STI571 and warfarin). Patients must not have a prior history of intracranial hemorrhage. Patients must not have any bleeding disorders. PT, INR and PTT must be < 1.5 times institutional upper limit of normal.
Total Enrollment: 60
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030311; 03-C-0311
Study Start Date: September 25, 2003
Record last reviewed: September 24, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069667
Other Meningioma Studies:
1. OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
2. STI571 to Treat Malignant Brain Tumors
3. ST1571 to Treat Patients with Recurrent Meningiomas
4. NF2 Natural History Consortium
Related Studies:
Other Meningioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
ST1571 to Treat Patients with Recurrent Meningiomas
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