Phase 2
N=64
Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)
Glioblastoma · Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00615927 ↗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
| Outcome | Result | p-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
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.