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Bevacizumab in Combination With Irinotecan for Malignant Gliomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Bevacizumab in Combination With Irinotecan for Malignant Gliomas


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

James J. Vredenburgh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

Pro00004091

NCT ID:

NCT00268359

Start Date:

May 2005

Completion Date:

October 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult glioblastoma
  • adult gliosarcoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710