Clinical Trials

12 studies in Glioma

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

   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

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

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

   Request Information Online
2. Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma Jacksonville, FL Rochester, MN View Summary
   Close

   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

   • Print Summary
   • View study details

   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
3. Study of Tissue and Blood Samples From Patients With High-Grade Glioma Jacksonville, FL Rochester, MN View Summary
   Close

   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

   • Print Summary
   • View study details
4. 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
   Close

   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

   • Print Summary
   • View study details

   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
                       
   

   Request Information Online
5. 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
   Close

   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

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

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

   Request Information Online
6. Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Jacksonville, FL Rochester, MN View Summary
   Close

   Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - To establish a maximum-tolerated dose of dasatinib combined with radiation and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I) (Phase I study closed to patient accrual on April 29, 2011 and has been completed) - To determine the efficacy of dasatinib in combination with radiotherapy and concomitant adjuvant temozolomide, and compare it with the standard of care approach, consisting of radiotherapy and temozolomide, followed by adjuvant temozolomide in these patients. (Phase II) (Phase II study opened to patient accrualon August 5, 2011) - To determine the relationship between tumor biomarkers and clinical outcome of patients treated with the dasatinib/radiotherapy/temozolomide combination. (Phase II) - To evaluate potential mechanisms of therapy resistance in recurrent tumor samples obtained at the time of surgery for recurrent disease. - To assess the impact of the addition of dasatinib to radiotherapy and temozolomide on the quality of life (QOL) of these patients, as assessed by FACT-Br, EORTC QLQ-C15-PAL, and EORTC QLQ-BN20. (Phase II) - To compare the results of the two most commonly used QOL tools, FACT-Br and EORTC QLQ C15-PAL plus BN20 and validate the use of EORTC QLQ-C15-PAL plus BN20 in these patients.(Phase II) OUTLINE: This is a multicenter, phase I dose-escalation study of dasatinib (Phase I study closed to patient accrual on April 29, 2011 and has been completed) followed by a randomized phase II study (Phase II study opened to patient accrual on August 5, 2011). - Phase I: - Course 1: Patients receive oral dasatinib once daily and oral temozolomide once daily on days 1-42. Patients undergo external-beam radiotherapy (EBRT), including intensity-modulated radiotherapy, 5 days a week for 6 weeks. - Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Phase II: Patients are stratified according to age (> 70 years vs ≤ 70 years). Patients are randomized to 1 of 2 treatment arms. - Arm I: - Course 1: Patients receive oral dasatinib once daily and oral temozolomide once daily on days 1-42. Patients undergo EBRT 5 days a week for 6 weeks. - Courses 2-7: Beginning 28-42 days after course 1, patients receive oral dasatinib once daily on days 1-28 and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. - Arm II: - Course 1: Patients receive oral placebo once daily on days 1-42 and temozolomide as in arm I. Patients also undergo EBRT as in arm I. - Courses 2-7: Beginning 28-42 days after course 1, patients receive oral placebo once daily on days 1-28 and temozolomide as in arm I. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Tissue samples are collected for correlative studies. Quality of life is assessed periodically using the FACT-Br, EORTC QLQ-C15-PAL v.1, and EORTC BN-20 questionnaires. After completion of study therapy, patients are followed up every 6 months for 5 years.

   NCT ID:

   NCT00869401

   IRB Number:

   09-001792

   • Print Summary
   • View study details

   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
7. Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma Jacksonville, FL Rochester, MN View Summary
   Close

   Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma

   Location:

   Jacksonville, FL Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To assess the anti-tumor activity (in terms of the tumor response rate using the RECIST criteria) of pazopanib (pazopanib hydrochloride) (GW786034) in patients with advanced malignant pheochromocytomas and paragangliomas. SECONDARY OBJEC TIVES: I. To assess safety profile of pazopanib. II. To assess duration of tumor response. III. To assess time to treatment failure. IV. To assess progression-free survival time. V. To assess overall survival time. TERTIARY OBJECTIVES: I. To examine the association between baseline CYP isoforms and the maximum pazopanib plasma level achieved during the first cycle of treatment. II. To examine whether tumor response is associated with plasma pazopanib levels achieved during the first cycle of treatment or baseline CYP isoforms. III. To examine whether severe toxicities leading to pazopanib dose reductions are associated maximum pazopanib level achieved during the first cycle of treatment or baseline CYP isoforms. IV. To examine changes in urinary catecholamine and/or metanephrine levels. V. To examine whether pazopanib-induced changes in urinary catecholamine and/or metanephrine levels during the first cycle of treatment may be associated with objective tumor response. VI. To examine associations between tumor response and somatic mutational status in archived tumors, or germline mutational status in patient's peripheral blood mononuclear cells, (presence of SDHD, SDHB, RET, VHL, neurofibromatosis type-1). VII. To examine associations between tumor response and tumor expression levels of HIF-1a, VEGF-R (total and phospho-) and microvessel density. OUTLINE: This is a multicenter study. Patients are stratified according to prior tyrosine kinase inhibitor (yes vs no). Patients receive pazopanib hydrochloride orally once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo urine and blood sample collection at baseline and periodically during study for correlative studies. After completion of study therapy, patients are followed up every 3-6 months for a maximum of 3 years.

   NCT ID:

   NCT01340794

   IRB Number:

   11-000923

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Keith C. Bible 507-284-2511
                       
   
   
   

   Request Information Online
8. Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas Rochester, MN View Summary
   Close

   Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments. Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors. In addition, the quality of life for children with low-grade gliomas is important and requires further study. This trial will incorporate an optional assessment using validated neuropsychological testing throughout treatment to evaluate the quality of life of the child being treated. Objective: To test the efficacy of Vinorelbine in a larger number of children with pediatric low-grade glioma that has returned or continues to grow. In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest. This cycle can then be repeated for up to 1-2 years if providing clinical benefit.

   NCT ID:

   NCT01497860

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Amulya Rao, MBBS 507-284-2652
                       
   
   
   

   Request Information Online
9. Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma Rochester, MN View Summary
   Close

   Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To identify the dose of vorinostat that is feasible when given in combination with radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). II. To compare 1-year event-free survival of patients with newly diagnosed HGG treated with vorinostat (using MTD) versus bevacizumab versus temozolomide when given in combination with RT followed by maintenance therapy with bevacizumab and temozolomide. (Phase II) III. To compare the event-free survival of patients with newly diagnosed HGG treated with the superior chemoradiotherapy (from phase II portion) versus temozolomide given in combination with RT followed by maintenance chemotherapy with bevacizumab and temozolomide. (Phase III) SECONDARY OBJECTIVES: I. To evaluate the anti-tumor activity, as measured by event-free survival (EFS), progression-free survival (PFS), and overall survival (OS), of patients with newly diagnosed HGG treated with vorinostat, bevacizumab, or temozolomide when given in combination with RT followed by maintenance chemotherapy with bevacizumab and temozolomide. II. To define and evaluate the toxicities of each of the treatment arms of the study. III. To conduct gene expression profiling and SNP arrays in patients with newly diagnosed HGG. IV. To assess telomerase activity, hTert expression, and telomere length in patients with newly diagnosed HGG. V. To document changes in perfusion and diffusion using MR imaging at baseline, prior to, during (prior to course 3), and after maintenance therapy with bevacizumab and temozolomide. VI. To correlate functional changes in tumor with responses to bevacizumab treatment using MR diffusion/perfusion imaging. VII. To correlate the results of the bevacizumab biology studies in serum or tumor with EFS. VIII. To explore the prognostic significance of MGMT status for patients newly diagnosed with HGG treated with combined surgery, radiation, chemotherapy, and anti-angiogenic therapy. OUTLINE: This is a multicenter, feasibility, dose-escalation study of vorinostat, followed by a phase II study, followed by a phase III study. FEASIBILITY STUDY: Patients undergo 3-D conformal radiotherapy (RT) or intensity-modulated RT 5 days a week for 6 weeks. Patients also receive vorinostat orally (PO) once daily on days 1-5. Courses repeat every week for 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and temozolomide PO on days 1-5. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. PHASE II STUDY: Patients are stratified according to extent of resection (near total resection or gross total resection vs other) and histology (glioblastoma multiforme vs other). Patients are randomized to 1 of 3 treatment arms. ARM I: Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the maximum-tolerated dose determined in the feasibility study. ARM II: Patients undergo RT as in arm I and receive temozolomide PO once daily for 42 days beginning on day 5 of RT. ARM III: Patients undergo RT as in arm I and receive bevacizumab IV over 30-90 minutes on days 22 and 36. Patients in all arms receive maintenance therapy as in the feasibility study. PHASE III study: Patients are randomized to 1 of 2 treatment arms. ARM IV: Patients receive RT and temozolomide as in phase II, arm II. ARM V: Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was established as the superior chemoradiotherapy arm in phase II. Patients in all arms receive maintenance therapy as in the feasibility study. Some patients undergo blood and tumor tissue sample (from surgery) collection for telomerase activity, hTert expression, telomere length, and gene expression profiling and SNP arrays analysis. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

   NCT ID:

   NCT01236560

   IRB Number:

   11-001749

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Amulya A. Nageswara Rao 507-538-7623
                       
   
   
   

   Request Information Online
10. Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma Rochester, MN View Summary
    Close

    Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma

    Location:

    Rochester, MN

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine the objective response rate in children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with Regimen A low-dose (20 mg/m²/dose) or Regimen B high-dose (115 mg/m²/dose) lenalidomide. SECONDARY OBJECTIVES: I. To estimate the event-free survival (EFS) (based on standard two-dimensional tumor measurements, determined by each institution) of children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with lenalidomide. II. To compare response categories and EFS across the 3 magnetic resonance (MR) sequences (T2-weighted, fluid attenuated inversion recovery [FLAIR], T1-weighted post-contrast). III. To correlate steady-state pharmacokinetics of lenalidomide (1 sample obtained between Days 5-21) with objective response and EFS. IV. To evaluate toxicities of long-term lenalidomide use. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. ARM I (regimen A): Patients receive low-dose lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. ARM II (regimen B): Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection between days 5-21 during course 1 for pharmacokinetic studies. After completion of study treatment, patients are followed up for up to 5 years.

    NCT ID:

    NCT01553149

    IRB Number:

    12-004726

    • Print Summary
    • View study details

    Who can I contact for additional information about this study?

    Rochester: Amulya A. Nageswara Rao 507-538-7623
                        
    
    
    

    Request Information Online

1. 1
2. 2
3. Next