Status:
COMPLETED
Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary objective: * To evaluate activity of imatinib mesylate and hydroxyurea among patients with progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month progression free survi...
Detailed Description
This is an open-label, single stage, uncontrolled, non-randomized Phase II study of continuous, daily doses of imatinib mesylate \& hydroxyurea in adult patients with progressive/recurrent Grade II lo...
Eligibility Criteria
Inclusion
- Patients with grade II LGG that is recurrent/progressive following prior surgical resection while on non-decreasing dose of corticosteroids
- \> 25percent enlargement of bidimensional measure/new lesions on sequential imaging new \&/or worsening neurologic deficits
- Patients with progressive/recurrent optic pathway tumors
- Patients have measurable disease on MRI/CT
- Interval of \> 4 wks between prior external beam radiation therapy (XRT)/chemo,\& enrollment on protocol unless there is unequivocal evidence of tumor progression \& patient has recovered from all expected toxicities associated with prior therapy. 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 not have had tumor biopsy \< 1 wk/surgical resection \< 2 wks 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 \> 18 yrs old
- Karnofsky Performance Status (KPS) of \> 60
- absolute neutrophil count (ANC) \> 1.5 x 10 9/L
- Hgb \> 9 g/dL
- Platelets \> 100 x 10 9/L
- K ≥ lower limit of normal (LLN)/correctable with supplements
- Ca ≥ LLN/correctable with supplements
- P ≥ LLN/correctable with supplements
- aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) \& Alanine transaminase (ALT)/ Serum Glutamic Pyruvate Transaminase (SGPT} \< 2.5 x ULN
- Serum bilirubin \< 1.5 x upper limit of normal (ULN)
- Serum creatinine \< 1.5 x ULN/measured 24hr Creatinine Clearance \> 50 mL/min/1.73m2
- Life expectancy ≥ 12wks
- Written informed consent obtained prior to screening procedures
Exclusion
- Prior progressive disease/toxicity grade ≥ 3 with prior hydroxyurea therapy
- Prior treatment with imatinib/other platelet derived growth factor (PDGF)-directed therapy
- Excessive risk of bleeding as defined by stroke \< 6 months, history of central nervous system (CNS)/intraocular bleed, or septic endocarditis
- Evidence of intratumor hemorrhage on pretreatment diagnostic imaging, except for stable post-operative gr1 hemorrhage
- 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/GI disease that may significantly alter absorption of imatinib
- Patients taking Coumadin
- Patients have received investigational drugs \< 2wks prior to entry on study/have not recovered from toxic effects of such therapy
- Patients have received biologic, immunotherapeutic/cytostatic agents \< 1 wk prior to entry on study/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, or if other primary malignancy is basal cell skin cancer/ cervical carcinoma in situ. Existence of any other malignant disease is not allowed
- Patients have had any surgery other than resection of brain tumor \< 2 wks prior to entry on study/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
- Gr2 /\> peripheral edema/central/systemic fluid collections
- Patients who enroll on arm A must have not received any EIAC for \> 2 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 magnetic resonance (MR) scanners
- Claustrophobia
- Obesity
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00615927
Start Date
February 1 2006
End Date
June 1 2012
Last Update
March 15 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710