Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
This study has been completed.
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00352521
First received: July 13, 2006
Last updated: February 18, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: bevacizumab Drug: irinotecan Procedure: dynamic contrast-enhanced magnetic resonance imaging |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Assessed by DCE-MRI
Secondary Outcome Measures:
- Overall Survival and Tumor Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | April 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab and irinotecan
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.
|
Drug: bevacizumab
Other Name: Avastin
Drug: irinotecan
Other Name: Camptosar
Procedure: dynamic contrast-enhanced magnetic resonance imaging
|
Detailed Description:
OBJECTIVES:
Primary
- Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas.
Secondary
- Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant gliomas.
- Determine the predictive value of DCE-MRI in patients with recurrent malignant gliomas treated with bevacizumab and irinotecan.
- Describe the activity of the combination of bevacizumab with irinotecan as measured by response rate and progression-free survival.
- Describe the toxicity associated with the administration of bevacizumab with irinotecan.
OUTLINE: Patients receive bevacizumab IV on days 1, 15, and 29 and irinotecan IV on days 2, 15, and 29 during the first 6-week cycle. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients also undergo dynamic contrast-enhanced MRI 4 times.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352521
Locations
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Investigators
| Study Chair: | James J. Vredenburgh, MD | Duke Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00352521 History of Changes |
| Other Study ID Numbers: | Pro00012387, DUMC-8053-05-12R0, CDR0000481476 |
| Study First Received: | July 13, 2006 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Duke University:
|
adult anaplastic astrocytoma adult mixed glioma adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor |
adult glioblastoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult pineal gland astrocytoma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Irinotecan Bevacizumab |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013