Clinical trial · Interventional
Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG
Phase I Dose Escalation of Gleevec in Combination With RAD001 Plus Hydroxyurea for Patients With Recurrent Malignant 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 determine maximum tolerated dose \& dose limiting toxicity of imatinib mesylate \& RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who are on \& not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs Secondary objective To assess safety \& tolerability of imatinib mesylate in combo w RAD001 \& hydroxyurea in this population To characterize single-dose \& repeated-dose pharmacokinetic profiles of imatinib mesylate \& RAD001 combo therapy in this pt population. To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 \& hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular permeability, perfusion \& relative tumor blood volume; to explore assessment of tumor cellularity \& tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion coefficient maps.
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 |
|---|---|---|---|
| Gleevec, RAD001, and Hydroxyurea | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Pts receiving EIACDs
- interventionNames
- Drug: Gleevec, RAD001, and Hydroxyurea
- type
- EXPERIMENTAL
- label
- 2
- description
- Pts not receiving EIACDs
- interventionNames
- Drug: Gleevec, RAD001, and Hydroxyurea
Primary outcomes (1)
- measure
- To determine MTD & DLT & Imatinib mesylate & RAD001 when combined w Hydroxyurea among pt w GBM
- timeFrame
- 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pts w confirmed GBM, GS, AA, AO \& AOA are presenting in 1st, 2nd/3rd recurrence/relapse * Pts without tumor biopsy \<1 wk/surgical resection \<2 wks prior to starting study drug * For stratum of non-EIAED pts, each pts off all enzyme inducing anticonvulsants for \>2 wks prior to starting study drug * Pts should be on non-increasing dose of steroids for \>7 days prior to obtaining baseline Gd-MRI of brain * Pts should be on non-increasing dose of steroids for \>7 days prior to starting study drug * Pts w previous implantation of Gliadel may be eligible after discussion between investigator \& sponsor * Multifocal disease is eligible * Age \>18 yrs * KPS \>70 * 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 w supplement, Mg≥ LLN/correctable w 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\<0 mL/min/1.73m2, \& Cholesterol≤ 00 mg/dL \& triglyceride≤2.5 ULN * Life expectancy ≥12wks * Written informed consent obtained prior to any screening procedures Exclusion Criteria: * Pts w any peripheral neuropathy ≥CTCAE gr2 * Pts w unresolved diarrhea ≥CTCAE gr2 * History of impaired cardiac function * Obligate use of cardiac pacemaker, Congenital long QT syndrome, History or presence of ventricular or atrial tachyarrhythmias, Clinically significant resting bradycardia , Right bundle branch block + left anterior hemiblock * Other clinically significant cardiac diseases * Uncontrolled Db * Active or uncontrolled infection requiring intravenous antibiotics * Impairment of GI function/GI disease that may significantly alter absorption of Gleevec, hydroxyurea and/or RAD001 * Acute/chronic liver/renal disease * Other concurrent severe and/or uncontrolled medical condition that could cause unacceptable safety risks/compromise compliance w protocol * Treatment w any hematopoietic colony-stimulating factor ≤2wks prior to starting study drug. Erythropoietin is allowed * Pts w history of CHF/arrhythmias who are receiving treatment w digoxin/verapamil, \& treatment cannot be discontinued/switched to different drug prior to starting study drug * Pts taking warfarin sodium * Pts received treatment w PDGF/mTOR directed therapies * Pts received chemo ≤ 4wks prior to starting study drug/have not recovered from side effects of such therapy * Pts received immunotherapy ≤2 wks prior to starting study drug/have not recovered from side effects of such therapy * Pts received investigational drugs ≤4 wks prior to starting study drug/have not recovered from side effects of such therapy * Pts received XRT ≤4 wks prior to starting study drug/have not recovered from side effects of such therapy * Pts undergone major non-CNS surgery ≤2 wks prior to starting study drug/pts have not recovered from side effects of such therapy * Cardiac pacemaker, Ferromagnetic metal implants other than those approved as safe for use in MR scanners, Claustrophobia, Obesity * Female pts are pregnant/breast feeding,/adults of reproductive potential not employing effective method of birth control. Barrier contraceptives must be used throughout trial in both sexes. Oral, implantable/injectable contraceptives may be affected by cytochrome P450 interactions, \& are therefore not considered effective for study. Women of childbearing potential have negative serum pregnancy test 48hrs prior to administration of Gleevec, hydroxyurea and/or RAD001. * Known diagnosis of HIV infection * Pts w history of another primary malignancy that is currently clinically significant/currently requires active intervention * Pts unwilling to/unable to comply w protocol
References
Publications (0)
Data not yet available