Clinical trial · Interventional
Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)
Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent / Progressive Grade II Low-Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate & Hydroxyurea | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Astrocytoma
- description
- Grade II Astrocytoma
- interventionNames
- Drug: Imatinib Mesylate & Hydroxyurea
- type
- EXPERIMENTAL
- label
- Oligodendroglioma
- description
- Grade II Oligodendroglioma or oligoastrocytomas
- interventionNames
- Drug: Imatinib Mesylate & Hydroxyurea
Primary outcomes (1)
- measure
- 12-month Progression Free Survival (PFS)
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 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 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 \< 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
References
Publications (0)
Data not yet available