Expired Study
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Durham, North Carolina 27710


Purpose:

Primary objective: - To evaluate activity of imatinib mesylate & hydroxyurea among patients with recurrent meningioma as measured by 6 month progression free survival Secondary objectives : - To evaluate time to progression, overall survival & objective response rate among patients with recurrent meningioma treated with imatinib + hydroxyurea - To assess safety & tolerability of imatinib mesylate + hydroxyurea in this population


Study summary:

This is an open-label, 2-stage, uncontrolled, non-randomized phase II study of continuous, daily doses of imatinib mesylate & hydroxyurea in adult patients with recurrent or relapsing meningioma. Treatment cycle is defined as imatinib mesylate & hydroxyurea administered daily for 28 days for purpose of scheduling evaluations. All patients who receive 1 or more doses of either imatinib mesylate or hydroxyurea will be evaluable for toxicity, whereas all patients who receive minimum of 14 consecutive days of study regimen will be evaluable for response. Patients who discontinue therapy prior to receiving 14 consecutive days of study regimen will be regarded as ineligible for evaluation of response & will be replaced.


Criteria:

Inclusion Criteria: - Patients with confirmed meningioma that is recurrent/progressive following prior surgical resection - Patients have measurable disease on MRI using gadolinium-enhanced T1 sequences - Interval of >4 wks between prior XRT/chemo, & enrollment on protocol unless there is unequivocal evidence of tumor progression & pt has recovered from all expected toxicities associated w prior therapy. However, patients treated w chemo agents such as VP-16 who would normally be retreated after shorter intervals may be treated at usual starting time even if <4 wks from last prior dose of chemo - Patients with tumor biopsy <1 week or surgical resection <2 weeks prior to starting study drug - Patients enrolling on arm B must be on >1 enzyme inducing anticonvulsants for >2 wks prior to starting study drug - Patients should be on non-increasing dose of steroids for >7 days prior to obtaining baseline Gd-MRI of brain - Patients should be on non-increasing dose of steroids for >7 days prior to starting study drug - Multifocal disease is eligible - Age > 18yrs old - KPS of > 60 - Patients must have following laboratory values: - Hematology: - ANC > 1.5 x 10^9/L - Hgb> 9 g/dL - Platelets>100 x 10^9/L - Biochemistry: - K≥ LLN/correctable w supplement - Total Ca ≥ LLN/correctable with supplement - P ≥ LLN/correctable w supplement - AST/SGOT & ALT/SGPT < 2.5 x ULN - Serum bilirubin < 1.5 x ULN - Serum creatinine ,1.5 x ULN/measured 24hr CrCl> 50 mL/min/1.73m2 - Life expectancy ≥ 12wks - Written informed consent obtained prior to any screening procedures Exclusion Criteria: - Prior progressive disease/toxicity gr ≥3 w prior hydroxyurea therapy - Prior treatment with imatinib/other PDGF-directed therapy - Excessive risk of bleeding as defined by stroke<6 months, history of CNS/intraocular bleed,septic endocarditis - Evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative gr1 hemorrhage - Female patients who are pregnant/breast feeding,/adults of reproductive potential not employing effective method of birth control - Concurrent severe and/or uncontrolled medical disease that could compromise participation in study - Acute/chronic liver disease - Confirmed diagnosis of HIV infection - Impairment of GI function or GI disease that may significantly alter absorption of imatinib - Patients who are taking Coumadin - Patients who have received investigational drugs <2wks prior to entry on this study or who have not recovered from the toxic effects of such therapy - Patients who have received biologic, immunotherapeutic or cytostatic agents within 1wk prior to entry on this study/who have not recovered from toxic effects of such therapy - Patient ≤ 5 yrs free of another primary malignancy except: if other primary malignancy is not currently clinically significant/requiring active intervention,/if other primary malignancy is basal cell skin cancer/ cervical carcinoma in situ. Existence of any other malignant disease is not allowed - Patients who have had any surgery other than resection of brain tumor < 2 wks prior to entry on this study/who have not recovered from side effects of such therapy - Patients unwilling to/unable to comply with protocol - Active systemic bleeding, such as GI bleeding/gross hematuria - Gr 2/greater peripheral edema/central/systemic fluid collections - Patients who enroll on arm A must have not received any EIAC for at >wks prior to starting study regimen - Any of following exclusion criteria to MRI imaging: - Cardiac pacemaker - Ferromagnetic metal implants other than those approved as safe for use in MR scanners - Claustrophobia - Obesity


NCT ID:

NCT00611234


Primary Contact:

Principal Investigator
David A. Reardon, MD
Duke University Health System


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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