Clinical trial · Interventional
Imatinib Mesylate, Vatalanib, and Hydroxyurea in Treating Patients With Recurrent or Relapsed Malignant Glioma
Phase I Dose Escalation of Gleevec in Combination With PTK787/ZK 222584 (PTK/ZK) Plus Hydroxyurea
- 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)
RATIONALE: Imatinib mesylate, vatalanib, and hydroxyurea may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate and vatalanib together with hydroxyurea may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate and vatalanib when given together with hydroxyurea in treating patients with recurrent or relapsed malignant glioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hydroxyurea | Drug | Hydroxyurea | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| vatalanib | Drug | Vatalanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gleevec + PTK787/ZK 22584 + Hydroxyurea
- description
- Patients with recurrent or relapsing glioblastoma multiforme (GBM) will be given daily doses of Gleevec and PTK787/ZK 22584 orally in combination with fixed doses of hydroxyurea.
- interventionNames
- Drug: hydroxyurea
- Drug: imatinib mesylate
- Drug: vatalanib
Primary outcomes (1)
- measure
- Maximum tolerated dose and dose-limiting toxicity of imatinib mesylate and vatalanib when administered with hydroxyurea
- timeFrame
- 1 Year
Secondary outcomes (4)
- measure
- Safety
- timeFrame
- 1.5 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Grade 3 or 4 disease * In first, second, or third recurrence or relapse * Multifocal disease allowed PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy ≥ 12 weeks * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin \> 9 g/dL * Platelet count \> 100,000/mm\^3 * Potassium normal\* * Total calcium (corrected) normal\* * Magnesium normal\* * Phosphorus normal\* * aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Negative proteinuria by dipstick OR total urinary protein ≤ 500 mg with creatinine clearance ≥ 50 mL/min by 24-hour urine collection * Creatinine \< 1.5 times ULN OR creatinine clearance \> 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No acute or chronic liver or renal disease * left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram * No complete left bundle branch block * No obligate use of a cardiac pacemaker * No congenital long QT syndrome * No history of or current ventricular or atrial tachyarrhythmias * No clinically significant resting bradycardia (i.e., heart rate \< 50 beats/minute) * No right bundle branch block with left anterior hemiblock (bifascicular block) * No uncontrolled hypertension ≥ grade 2, history of labile hypertension, or history of poor compliance with an antihypertensive regimen * No concurrent unstable angina pectoris or angina pectoris within the past 3 months * No congestive heart failure (CHF) * No history of CHF or arrhythmias requiring concurrent digoxin or verapamil * No acute myocardial infarction within the past 3 months * No other impaired cardiac function or clinically significant cardiac disease * No peripheral neuropathy ≥ grade 2 * No unresolved diarrhea ≥ grade 2 * No uncontrolled diabetes * No active or uncontrolled infection requiring intravenous antibiotics * No impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib, hydroxyurea, and/or everolimus, including any of the following: * Ulcerative disease * Uncontrolled nausea, vomiting, or diarrhea * Malabsorption syndrome * Small bowel resection * No other concurrent severe and/or uncontrolled medical condition that would preclude study participation or compliance * No known HIV positivity * No other primary malignancy that is clinically significant or requires active intervention NOTE: \*Supplement allowed PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 2 weeks since prior tumor biopsy (4 weeks since prior surgical resection) * Prior polifeprosan 20 with carmustine implant (Gliadel® wafer) allowed at discretion of principal investigator * Prior hydroxyurea allowed * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 1 week for metronomic-dosed chemotherapy \[e.g., daily etoposide hydrochloride or cyclophosphamide\]) and recovered * More than 4 weeks since prior radiotherapy and recovered * More than 2 weeks since prior immunotherapy and recovered * More than 4 weeks since prior investigational drugs and recovered * No prior platelet-derived growth factor- or vascular endothelial growth factor-directed therapies * More than 2 weeks since prior hematopoietic colony-stimulating factor (e.g., filgrastim \[G-CSF\] or sargramostim \[Granulocyte-macrophage colony-stimulating factor (GM-CSF)\]) * Prior epoetin alfa allowed * No concurrent warfarin
References
Publications (1)
- RESULTReardon DA, Egorin MJ, Desjardins A, Vredenburgh JJ, Beumer JH, Lagattuta TF, Gururangan S, Herndon JE 2nd, Salvado AJ, Friedman HS. Phase I pharmacokinetic study of the vascular endothelial growth factor receptor tyrosine kinase inhibitor vatalanib (PTK787) plus imatinib and hydroxyurea for malignant glioma. Cancer. 2009 May 15;115(10):2188-98. doi: 10.1002/cncr.24213. PMID 19248046