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Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma Clinical research trials and Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma. Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma clinical trial. Subjects often receive the most expert healthcare possible for their Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma  Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
For Condition: adult brain tumor
Status: Recruiting
Sponsor(s): North American Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for recurrentglioma and meningioma. PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectablemalignant glioma or meningioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent malignant glioma or meningioma. - Determine the safety profile of this drug in these patients. - Determine the pharmacokinetics of this drug, with or without concurrent enzyme-inducing anti-epileptic drugs (EIAEDs), in these patients. (Stratum of patients currently taking EIAEDs closed to accrual as of 05/15/2003 for phase I and phase II) - Determine angiogenic activity in vivo using functional neuro-imaging studies and in vitro with assays of serum angiogenic peptides. - Determine the efficacy of this drug, in terms of 6-month progression-free survival and objective tumor response, in these patients. OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no). Patients in cohorts 1 and 2 receive oral imatinib mesylate (STI571) once daily on days 1-28. Patients in cohorts 3-5 receive oral STI571 twice daily on days 1 and 3-28 of the first course and on days 1-28 of subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients receive oral STI571 at the MTD determined in phase I, 1-2 times daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months. (Glioblastoma multiforme patients excluded from phase II as of 05/13/2003).
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or unresectable malignant glioma - Glioblastoma multiforme (phase I only) - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Anaplastic mixed oligoastrocytoma - Malignant astrocytoma not otherwise specified - Gliosarcoma - Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR - Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only) - No prior intracranial hemorrhage - Failed prior radiotherapy - Progressive or recurrent disease by MRI or CT scan and/or resection - PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery - Stable dose of steroids for 5-7 days prior to MRI or CT scan PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 8 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT less than 2 times ULN - No significant hepatic disease Renal: - Creatinine less than 1.5 mg/dL - Creatinine clearance at least 60 mL/min - No significant renal disease Cardiovascular: - No significant cardiac disease - No deep venous or arterial thrombosis within the past 6 weeks Pulmonary: - No pulmonary embolism within the past 6 weeks Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for up to 6 months after study participation - No other serious concurrent medical illness - No serious active infection - No concurrent disease that would obscure toxicity or alter drug metabolism - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior interferon or thalidomide and recovered - No concurrent immunotherapy - No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: - Recovered from prior chemotherapy - At least 4 weeks since prior cytotoxic therapy - At least 2 weeks since prior vincristine - At least 6 weeks since prior nitrosoureas - At least 4 weeks since prior temozolomide - At least 3 weeks since prior procarbazine - Prior polifeprosan 20 with carmustine implant (Gliadel wafer) allowed - Prior radiosensitizers allowed - No other concurrent chemotherapy - Phase I only: - Prior chemotherapy required for anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic mixed oligoastrocytoma - Prior treatment for up to 3 relapses allowed - Phase II only: - Prior chemotherapy not required - Prior treatment for up to 2 relapses allowed Endocrine therapy: - See Disease Characteristics - At least 1 week since prior tamoxifen and recovered - No concurrent anticancer hormonal therapy Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - Recovered from prior surgical resection of recurrent or progressive disease Other: - At least 1 week since prior non-cytotoxic agents and recovered - At least 1 week since prior tretinoin and recovered - At least 2 weeks since prior drugs that affect hepatic metabolism - No other concurrent investigational agents - No concurrent warfarin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickWen, Study Chair, Dana-Farber/Harvard Cancer Center
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-6220
United States
Recruiting John Kuhn 210-567-8355
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lisa DeAngelis 212-639-7123
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Timothy Cloughesy 310-825-5321
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Wai-Kwan Yung 713-794-1285
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Frank Lieberman 412-692-2600
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0128
United States
Recruiting Michael Prados 415-353-9510
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9154
United States
Recruiting Karen Fink 214-648-4730
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0316
United States
Recruiting Larry Junck 734-936-7910
Additional Information:
Study ID Numbers: CDR0000068437; UCLA-0101024,NABTC-9908,NCI-01-C-0243
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010049
Other Adult Brain Tumor Studies:
1. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer
2. BMS-247550 in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
4. Antineoplaston Therapy in Treating Patients With Brain Tumors
5. Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
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Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
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