Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma

NCT00352521 | Completed Phase 2 DMC

• 3 other identifiers: Pro00012387DUMC-8053-05-12R0CDR0000481476
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Brain and Central Nervous System Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)

  Assessed by DCE-MRI

  1 year

Secondary Outcomes (2)

• Overall Survival and Tumor Response

  2 years

• Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage

  2 years

Study Arms (1)

Bevacizumab and irinotecan

EXPERIMENTAL

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; Drug: irinotecan; Procedure: dynamic contrast-enhanced magnetic resonance imaging

Interventions

bevacizumab DRUG

Also known as: Avastin

Bevacizumab and irinotecan

irinotecan DRUG

Also known as: Camptosar

Bevacizumab and irinotecan

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Bevacizumab and irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Glioma; Glioblastoma; Gliosarcoma; Brain Neoplasms; Ependymoma; Oligodendroglioma

Interventions

Bevacizumab; Irinotecan

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• James J. Vredenburgh, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: July 1, 2009
• Last Updated: July 22, 2014

Record last verified: 2013-02

Locations

US (1)