Clinical trial · Interventional
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
- 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: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan may kill more tumor cells. Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II trial is studying how well giving bevacizumab together with irinotecan works in treating patients with recurrent malignant glioma and how well MRI predicts response to treatment.
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 |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab and irinotecan
- description
- The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule. The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule. If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.
- interventionNames
- Drug: bevacizumab
- Drug: irinotecan
- Procedure: dynamic contrast-enhanced magnetic resonance imaging
Primary outcomes (1)
- measure
- Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
- timeFrame
- 1 year
- description
- Assessed by DCE-MRI
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of any of the following malignant gliomas: * Glioblastoma multiforme * Anaplastic astrocytoma * Grade 3 or greater WHO astrocytic, oligodendroglial, or mixed glial tumors that were initially diagnosed by histologic examination of a tumor specimen obtained from biopsy or resection * Recurrent disease * No more than 3 prior recurrences * Measurable recurrent or residual primary CNS neoplasm on contrast-enhanced MRI or CT scan * No evidence of CNS hemorrhage on baseline MRI or CT scan PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Hematocrit \> 29% * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 125,000/mm³ * Creatinine \< 1.5 mg/dL * SGOT \< 1.5 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No active infection * No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: * At least 6 weeks since prior surgical resection * More than 28 days since prior major surgical procedure or open biopsy * More than 7 days since prior minor surgical procedure, fine-needle aspirations, or core biopsies * At least 6 weeks since prior chemotherapy\* * At least 4 weeks since prior radiotherapy\* * No concurrent immunosuppressive agents * No concurrent therapeutic anticoagulation * Concurrent corticosteroids allowed if dose has been stable for 1 week prior to study entry NOTE: \* Unless there is unequivocal evidence of progressive disease
References
Publications (0)
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