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Phase 2 N=64 Treatment

Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)

Glioblastoma · Gliosarcoma

Enrolled (actual)
64
Serious AEs
20.3%
Results posted
Mar 2013
Primary outcome: Primary: 12-month Progression Free Survival (PFS) — 43.8; 34.4 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Imatinib Mesylate & Hydroxyurea (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Apr 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
12-month Progression Free Survival (PFS)
43.8; 34.4
SECONDARY
Median Progression-free Survival
43.5; 43.3
SECONDARY
Median Overall Survival (OS)
NA; NA
SECONDARY
Objective Response Rate
0; 0
SECONDARY
Safety and Tolerability of Gleevec + Hydroxyurea in Patients With Low-grade Gliomas
10; 3; 28; 28

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 survival Secondary objectives: * To evaluate progression-free survival (PFS), overall survival and objective response rate among patients with progressive/recurrent grade II LGG treated with imatinib mesylate plus hydroxyurea * To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population

Eligibility Criteria

Inclusion Criteria

  • 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 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} 50 mL/min/1.73m2
  • Life expectancy ≥ 12wks
  • Written informed consent obtained prior to screening procedures

Exclusion Criteria

  • 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 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00615927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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