Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Katy Peters
Study ID
NCT00979017
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme
  • Gliosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Avastin — DRUG
    Avastin, by intravenous infusion, 10 mg/kg every 14 days
  • Temozolomide — DRUG
    Oral temozolomide at 200 mg/m2 daily for 5 days
  • Irinotecan — DRUG
    Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)

Study Details

The primary objective of the study is to determine the efficacy of Avastin in combination with temozolomide and irinotecan in terms of response rate. The secondary objectives are to describe the overall and progression-free survivals of unresectable patients treated with upfront Avastin, temozolomide and irinotecan and to assess the safety of Avastin, temozolomide and irinotecan in unresectable glioblastoma patients. This is a phase II study with the combination of Avastin, temozolomide and irinotecan for unresectable or multifocal World Health Organization (WHO) grade IV malignant glioma patients. Patients will receive up to four cycles of Avastin, temozolomide and irinotecan. Approximately 41 subjects will take part in this study at Duke.

Key Dates

Start date
Nov 30, 2009
Status verified
Feb 2014
Primary completion
Feb 28, 2011
Completion
Jan 31, 2013

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Avastin in combination with temozolomide and irinotecan
    Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.

Primary Outcome Measure

Response Rate [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Preston Robert Tisch Brain Tumor Center at Duke University Medical CenterDurhamNorth Carolina27710-

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The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center· Durham, NC

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