Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT01004874
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab (Avastin) at 10 mg/kg every other week during standard radiation therapy (XRT). Following XRT, bevacizumab will remain at 10 mg/kg every other week.
  • Temozolomide — DRUG
    Daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation therapy (XRT). Following XRT, temozolomide will be dosed at 150 mg/m2 daily the first 5 days of each 28-day cycle.
  • Radiation Therapy (XRT) — RADIATION
    Standard radiation therapy for approximately 6.5 weeks
  • Topotecan — DRUG
    Following standard radiation therapy, patients will receive topotecan on days 2 through 6 of each 28-day cycle at a dose of 1.5 mg/m2 for patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs) and 2.0 mg/m2 for patients taking EIAEDs.

Study Details

This is a phase II study of the combination of radiation therapy, temozolomide and Avastin followed by Avastin, temozolomide, and topotecan in grade IV malignant glioma patients.

Key Dates

First listed
Oct 30, 2009
Start date
Dec 30, 2009
Status verified
Mar 2022
Primary completion
Jul 31, 2012
Completion
Nov 2, 2021

Study Design

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

Arms

  • Experimental: Bevacizumab, XRT, Temozolomide, Topotecan
    Patients are treated with standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation. Following completion of radiation therapy, patients have a MRI and, if there is no evidence of disease progression, patients receive 12 cycles of Avastin, temozolomide, and topotecan. Beginning a minimum of 14 days after the last radiation treatment, the Avastin is dosed at 10 mg/kg every other week; temozolomide is given at 150 mg/m2 daily the first 5 days in combination with topotecan on days 2 through 6 at 1.5 mg/ m2 for patient not taking EIAEDs and 2.0 mg/ m2 for patients taking EIAEDs on days 2-6 of each 28-day.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
The Preston Robert Tisch Brain Tumor Center at DukeDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
The Preston Robert Tisch Brain Tumor Center at Duke· Durham, NC

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