Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Annick Desjardins
Study ID
NCT00953121
Phase
PHASE2
Status
Completed

Conditions

  • Malignant Glioma

Eligibility Criteria

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

Interventions

  • bevacizumab and CPT-11 and Carboplatin — DRUG
    Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.

Study Details

The purpose of this study is to determine whether Bevacizumab, CPT-11 and Carboplatin in combination are effective in the treatment of recurrent malignant glioma.

Key Dates

First listed
Aug 6, 2009
Start date
Sep 30, 2009
Status verified
Sep 2013
Primary completion
Jul 31, 2012
Completion
Jan 31, 2013

Study Design

Enrollment
104 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A-Grade IV No Failure
    Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin
  • Experimental: Cohort B-Grade III No Failure
    Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin
  • Experimental: Cohort C-Failed Prior Therapy
    Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies

Primary Outcome Measure

6 Month Progression-free Survival [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Health System· Durham, NC

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