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20 studies in Brain Tumor

  1. Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma Rochester, MN View Summary
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    Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - Compare event-free and overall survival of pediatric patients (3 to 7 years of age) with newly diagnosed standard-risk medulloblastoma treated with standard-dose vs reduced-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide. - Compare event-free and overall survival of these patients (8 to 21 years of age) treated with standard-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with this chemotherapy regimen. Secondary - Compare patterns of failure in patients treated with these regimens. - Compare the cognitive, auditory, and endocrinologic effects of these regimens in these patients. - Compare the audiologic and endocrinologic toxicity from these regimens in these patients. - Develop an optimal gene expression medulloblastoma outcome predictor. - Assess quality of life and functional status in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients will undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). Patients receive vincristine IV on days 8, 15, 22, 29, 36, and 43 (weeks 1-6) beginning 31 days after surgery.Patients 3 to 7 years of age are randomized to 1 of 2 chemoradiotherapy arms. Patients 8-21 years old are assigned to arm II. - Chemoradiotherapy:Patients will undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6). Patients receive vincristine IV on days 8, 15, 22, 29, 36, and 43 (weeks 1-6) beginning 31 days after surgery. Patients 3 to 7 years of age are randomized to 1 of 2 radiotherapy arms (arms I and II). Patients 8-21 years old are assigned to arm II. - Radiotherapy (first randomization): - Arm I: Patients undergo reduced-dose craniospinal radiotherapy with boost. - Arm II: Patients undergo standard-dose craniospinal radiotherapy with boost. All patients are then randomized to 1 of 2 chemoradiotherapy arms (arms III and IV). - Radiotherapy boost (second randomization): - Arm III: Patients will undergo radiotherapy boost to the entire posterior fossa. - Arm IV: Patients will undergo radiotherapy boost to the tumor bed only. - Maintenance chemotherapy: Beginning 4 weeks after completion of chemoradiotherapy, patients receive 2 different regimens of maintenance chemotherapy for a total of 9 courses. Each course in regimen A is 6 weeks (42 days) in duration. Each course in regimen B is 4 weeks (28 days) in duration. - Regimen A (courses 1, 2, 4, 5, 7, and 8): Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49. - Regimen B (courses 3, 6, and 9): Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at 3-6 months after completion of radiotherapy and at 3-4 years after study entry. Neurocognitive function may also be assessed. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

    NCT ID:

    NCT00085735

    IRB Number:

    1617-04

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


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  2. Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme Rochester, MN View Summary
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    Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - Determine the safety and toxicity of intratumoral and/or resection cavity administration of a recombinant, attenuated Edmonston B vaccine strain derivative of measles virus genetically engineered to produce human carcinoembryonic antigen (CEA) in patients with recurrent glioblastoma multiforme. - Determine the maximum tolerated dose of this oncolytic virus in these patients. - Determine viral gene expression at each dose level as manifested by CEA titers in patients treated with this oncolytic virus. - Assess viremia, viral replication, and measles virus shedding/persistence after intratumoral administration of this oncolytic virus. - Assess humoral and cellular immune response to the injected virus in these patients. Secondary - Determine, preliminarily, the antitumor efficacy of this vaccine in these patients. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 sequential treatment groups. - Group 1 (resection cavity administration): Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by recombinant measles virus encoding human carcinoembryonic antigen (MV-CEA) administered into the resection cavity over 10 minutes. - Group 2 (intratumoral and resection cavity administration): Patients undergo placement of a catheter within the tumor, followed by MV-CEA administration into the tumor through the catheter over 10 minutes on day 1. Patients undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around the tumor bed. In both groups, cohorts of 1-6 patients receive escalating doses of MV-CEA 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. Once the MTD in group 1 has been determined, patients are assigned to group 2. The MTD in group 1 is used to determine the starting dose in group 2. At least 10 patients are treated at the MTD determined in group 2. Biopsy specimen, resected tumor, normal tissue, and peripheral blood are collected during study for immunologic and biomarker correlative studies, including analysis of CD46 receptor levels (by immunohistochemistry [IHC]), measles virus N protein (by IHC), measles and viral gene expression and replication (by in situ hybridization), CEA monitoring (by immunoassay), measles virus N mRNA (by reverse transcriptase-polymerase chain reaction), and measles virus immunity. Assessments of immune competence and peripheral response to viral administration are also performed. After completion of study treatment, patients are followed periodically for up to 15 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

    NCT ID:

    NCT00390299

    IRB Number:

    06-004440

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


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  3. Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor Rochester, MN View Summary
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    Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - Determine whether carboplatin radiosensitization increases long-term, event-free survival of pediatric patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumors. - Determine whether isotretinoin increases long-term, event-free survival of these patients. Secondary - Compare residual disease response to radiotherapy alone versus radiotherapy and carboplatin in these patients. - Identify molecular prognostic indicators suitable for patient stratification in future trials. OUTLINE: This is a randomized, open-label, factorial-designed, multicenter study. Patients are stratified according to location of disease and dissemination status (M0 medulloblastoma with > 1.5 cm² residual tumor vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with < 1.5 cm² residual tumor vs M0 SPNET with > 1.5 cm² residual tumor vs M+ SPNET vs M0 diffusely anaplastic medulloblastoma ). Patients are randomized to 1 of 4 treatment arms. - Arm I (standard chemoradiotherapy and standard maintenance therapy): - Chemoradiotherapy: Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and receive vincristine IV over 1 minute on days 1, 8, 15, 22, 29, and 36. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive cisplatin IV over 6 hours on day 1, vincristine IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. - Arm II (standard chemoradiotherapy plus carboplatin and standard maintenance therapy): - Chemoradiotherapy: Patients receive carboplatin IV over 15 minutes once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and undergo radiotherapy and receive vincristine as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive maintenance therapy as in arm I. - Arm III (standard chemoradiotherapy, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin): - Chemoradiotherapy: Patients undergo chemoradiotherapy as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive oral isotretinoin twice daily on day 1 and days 16-28 and cisplatin, vincristine, cyclophosphamide, and G-CSF as in arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy. - Continuation therapy: Patients receive oral isotretinoin twice daily on days 15-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. - Arm IV (standard chemoradiotherapy plus carboplatin, standard maintenance therapy plus isotretinoin, and continuation therapy with isotretinoin): - Chemoradiotherapy: Patients undergo chemoradiotherapy as in arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy. - Maintenance therapy: Patients receive maintenance therapy as in arm III. Patients then proceed to continuation therapy. - Continuation therapy: Patients receive continuation therapy as in arm III. After completion of study treatment, patients are followed up periodically for up to 10 years. PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

    NCT ID:

    NCT00392327

    IRB Number:

    07-004144

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


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  4. Neuropsychological and Behavioral Testing in Young Patients With Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET) Rochester, MN View Summary
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    Neuropsychological and Behavioral Testing in Young Patients With Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET)

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: - To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological and behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points in children with medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET). - To utilize a standardized battery of age-appropriate neuropsychological and behavioral tests in conjunction with COG Phase III clinical trials to evaluate cognitive, social, emotional, and behavioral functioning over time. OUTLINE: This is a multicenter study. Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist. The Battery consists of tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function, adoptive function, and quality of life. Additionally, parents complete a parent-report questionnaire to gather information about patient's function in terms of attention, memory, executive abilities, and behavioral, social, and emotional adaption.

    NCT ID:

    NCT00772200

    IRB Number:

    09-000348

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


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  5. Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma Rochester, MN View Summary
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    Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: - Evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. - Assess the prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q; the expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75^NTR) receptors; and telomerase activity in these patients. - Compare the independent clinical significance of these biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome in these patients. - To prospectively analyze the concordance between detection of MYCN amplification in tumor samples and quantitative detection of MYCN DNA in serum, and to analyze the prognostic significance of MYCN amplification as detected in serum samples. - To build a database that includes information regarding the presentation and natural history of neuroblastoma-associated health problems including, but not limited to, opsoclonus myoclonus ataxia (OMA) and/or spinal cord compression. - Maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and RNA, tumor touch preparations, histology slides and blocks, cell lines, and paired normal DNA obtained at time of diagnosis, second-look surgery, and relapse for future research studies. - Build a database of known biological prognostic factors for patients on therapeutic studies. OUTLINE: This is a multicenter study. Patients are stratified according to International Neuroblastoma Staging System stage (stage 1 vs stage 2A vs stage 2B vs stage 3 vs stage 4 vs stage 4S) and age (under 365 days vs 365 days and over). Tumor samples are obtained at the time of surgery (diagnosis). Tumor samples may also be obtained at the time of second-look surgery and/or relapse. Blood and bone marrow samples are also obtained. MYCN copy number is analyzed by fluorescent in situ hybridization (FISH). Tumor cell ploidy is determined by flow cytometric analysis. Allelic status of 1p36, 11q23, and 14q32 is determined by multiplexed fluorescence polymerase chain reaction (PCR). Real-time quantitative PCR and FISH are used to determine 17q gain. Neurotrophin and neurotrophin receptor expression and the level of telomerase RNA expression is determined by reverse transcription-PCR. Telomerase activity is assessed by a telomeric repeat amplification protocol assay in patients with stage 2 or 4S disease. Patients are followed within 2 weeks and then annually (if not on a concurrent therapeutic study). PROJECTED ACCRUAL: Approximately 10,000 patients will be accrued for this study within 6 years.

    NCT ID:

    NCT00904241

    IRB Number:

    776-01

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


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  6. Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors Rochester, MN View Summary
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    Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: - Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children's Oncology Group institutions. - Provide a repository for long-term storage of specimens from these patients. - Make these specimens available to qualified researchers to understand the biology of pediatric brain tumors. OUTLINE: This is a multicenter study Brain tumor tissue and blood specimens are collected from patients and banked for future study. PROJECTED ACCRUAL: An unlimited number of specimens will be collected.

    NCT ID:

    NCT00919750

    IRB Number:

    1741-05

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        


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  7. Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma Jacksonville, FL Rochester, MN View Summary
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    Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma

    Location:

    Jacksonville, FL Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grade gliomas. - To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients. Secondary - To determine whether combination therapy with temozolomide and radiotherapy improves or maintains cognition and quality of life compared to radiotherapy alone. - To compare the toxicities (severe or worse [≥ grade 3]) of radiotherapy with vs without temozolomide in these patients. - To assess the impact of the presence or absence of 1p and 19q deletion on PFS and OS. - To determine the impact of 1p and 19q status on PFS and OS of patients treated with temozolomide. - To create a tumor and tissue bank, including plasma and germ line DNA, within the ECOG Pathology Coordinating Office. OUTLINE: This is a multicenter study. Patients are stratified according to age (< 40 years vs ≥ 40 years), 1p and 19q status (both deleted vs either/both intact vs undeterminable), pre-operative maximum tumor diameter (< 6 cm vs ≥ 6 cm [based on T2 or FLAIR MRI]), Karnofsky performance status (60-70% vs 80-100%), and contrast enhancement on pre-treatment MRI scan (present vs absent). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily 5 days a week for 5½ weeks (28 fractions). - Arm II: Patients undergo radiotherapy as in arm I and receive concurrent oral temozolomide once daily for 5½ weeks. Beginning 28 days after completion of chemoradiotherapy, patients receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Some patients undergo quality-of-life and neurocognitive (e.g., visual scanning speed, divided attention, language, memory, and fine motor skills) assessments at baseline, annually until disease progression, and at the time of disease progression. Tumor tissue samples are collected at baseline for confirmation of diagnosis and determination of 1p and 19q deletion status. Peripheral blood, serum, and additional tumor tissue samples may be collected for further research studies. After completion of study treatment, patients are followed up periodically for up to 15 years.

    NCT ID:

    NCT00978458

    IRB Number:

    10-003313

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        

    Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        

    Request Information Online
  8. Study of Tissue and Blood Samples From Patients With High-Grade Glioma Jacksonville, FL Rochester, MN View Summary
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    Study of Tissue and Blood Samples From Patients With High-Grade Glioma

    Location:

    Jacksonville, FL Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: - To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG) high-grade glioma trials conducted since 1979. - To evaluate alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y using PCR analysis of microsatellite repeats and FISH. - To determine DNA ploidy by flow cytometric analysis. - To examine various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53. - To evaluate additional markers identified by the Glioma Markers Network. - To compare the incidence of markers in the major histologic subtypes (anaplastic astrocytoma [AA], anaplastic oligoastrocytoma [AOA], glioblastoma multiforme [GBM]) and to assess their correlation in the total group, as well as within each of these subtypes. - To compare the ploidy determinations by FISH and flow cytometry. OUTLINE: Paraffin-embedded tissue and peripheral blood samples, previously or currently collected from clinical trials participants at the time she/he enrolled in the trial, are evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor markers, frequency distributions of all tumor markers and histological and clinical variables by polymerase chain reaction, IHC, flow cytometry, and FISH analysis.

    NCT ID:

    NCT01004887

    IRB Number:

    582-95
  9. Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN View Summary
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    Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme

    Location:

    Jacksonville, FL Scottsdale and Phoenix, AZ Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - Determine the maximum-tolerated dose of dasatinib in combination with bevacizumab in patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. (Phase I*) - Assess the safety and adverse events of this regimen in these patients. (Phase I*) - Estimate and compare the efficacy of these regimens in these patients as measured by progression-free survival at six months. (Phase II) Secondary - Describe any preliminary evidence of antitumor activity. (Phase I*) - Describe the overall toxicity associated with this regimen in these patients. (Phase I*) - Estimate and compare the efficacy of these regimens in these patients as measured by overall survival (Phase II) - Assess the impact of these regimens on the patient's quality of life using FACT-Br (no longer assessed as of 5/18/2009) (newly added as of 2/2/2010). (Phase II) - Assess the time to disease progression. (Phase II) - Assess the safety and toxicity of these regimens in this patient population. (Phase II) - Determine the relationship between tumor biomarkers and clinical outcome of patients treated with these regimens. (Phase II) (exploratory) - Assess the utility of dynamic contrast-enhanced MRI as a predictor of response to these regimens. (Phase II) (exploratory) - To assess the utility of MRI diffusion-weighted images (DWI), and specifically the apparent diffusion coefficient (ADC), as a predictor of response and survival in patients treated with bevacizumab/dasatinib combination treatment. (Phase II) (exploratory) - Bank leftover tissue for future NCCTG studies. (Phase II) (exploratory) NOTE: *Phase I completed. OUTLINE: This is a multicenter, phase I, dose-escalation study (Phase I completed) of dasatinib followed by a phase II randomized study. Patients are grouped according to study (1 vs 2). Patients in the phase II portion are stratified according to age (> 70 years of age vs ≤ 70 years of age), and ECOG performance status (0 vs 1 or 2). Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral dasatinib once or twice daily on days 1-14 until the maximum-tolerated dose (MTD) is determined. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. (Phase I completed) Phase II (patients are randomized to 1 of 2 treatment arms): - Arm I: Patients receive bevacizumab as in phase I and dasatinib at the MTD as determined in phase I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive bevacizumab as in phase I and oral placebo once or twice daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed by FACT-Br questionnaire at baseline and prior to every other course (no longer assessed as of 5/18/2009)(newly added as of 2/2/2010). Tissue samples are collected at baseline for biomarker studies and assessed by IHC, RT-PCR, and FISH. Patients undergo dynamic contrast-enhanced MRI at baseline, day 3 of course 1, and day 1 of course 2. After completion of study therapy, patients are followed up periodically for up to 3 years.

    NCT ID:

    NCT00892177

    IRB Number:

    09-002385

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        
    Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        
    Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        

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  10. Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma Rochester, MN View Summary
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    Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies. II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning. SECONDARY OBJECTIVES: I. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival. OUTLINE: Beginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy. After completion of study treatment, patients are followed up every year for 5 years.

    NCT ID:

    NCT01165632

    IRB Number:

    10-001904

    Who can I contact for additional information about this study?

    Rochester: Mayo Clinic Clinical Trials Office 507-538-7623
                        


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