Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Bevacizumab in Combination With Irinotecan for Malignant Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268359
• Other study ID #: Pro00004091
• Secondary ID: DUMC-6771-05-1R0
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2005
• Last updated: July 18, 2014
• Start date: May 2005
• Est. completion date: October 2009

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 stop the growth of tumor cells by blocking 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 tumors cells.

PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.

Description:

OBJECTIVES:

Primary

• Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.

Secondary

• Determine the activity of this regimen, in terms of progression-free survival, in these patients.

OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2009
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:

• Glioblastoma multiforme

• Gliosarcoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy

• Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan

• Failed = 1 prior chemotherapy regimen (with or without radiotherapy)

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Hematocrit > 29%

• Absolute neutrophil count > 1,500/mm^3

• Platelets > 125,000/mm^3

• Serum SGOT and bilirubin < 1.5 times upper limit of normal

• Creatinine < 1.5 mg/dL

• Urine protein:creatinine ratio = 1.0

• Blood pressure = 150/100 mmHg

• No unstable angina

• No New York Heart Association class II or greater congestive heart failure

• No myocardial infarction within the past 6 months

• No stroke within the past 6 months

• No clinically significant peripheral vascular disease

• No evidence of bleeding diathesis or coagulopathy

• No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

• At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression

• At least 6 weeks since prior surgical resection

• No previous major surgical procedures or open biopsies within 28 days prior to study entry

• No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry

• No anticipated need for major surgical procedures during the course of the study

• No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel

Study Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Desjardins A, Reardon DA, Herndon JE 2nd, Marcello J, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Bailey L, Bigner DD, Friedman AH, Friedman HS, Vredenburgh JJ. Bevacizumab plus irinotecan in recurrent WHO grade 3 malignant gliomas. Clin — View Citation

Sathornsumetee S, Cao Y, Marcello JE, Herndon JE 2nd, McLendon RE, Desjardins A, Friedman HS, Dewhirst MW, Vredenburgh JJ, Rich JN. Tumor angiogenic and hypoxic profiles predict radiographic response and survival in malignant astrocytoma patients treated — View Citation

Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Dowell JM, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Wagner M, Bigner DD, Friedman AH, Friedman HS. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety			Yes
Primary	Activity in terms of progression-free survival			No