Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01067469
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Standard Dose Bevacizumab — DRUG
    10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
  • Low Dose Bevacizumab — DRUG
    5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle.
  • Lomustine — DRUG
    Starting dose of 75 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle.

Study Details

The goal of this clinical research study is to learn if the combination of bevacizumab and lomustine can help to control glioblastoma. The safety of this combination will also be studied.

Key Dates

First listed
Feb 11, 2010
Start date
Jan 31, 2010
Status verified
Mar 2020
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
83 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard Dose Bevacizumab
    Bevacizumab 10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.
  • Experimental: Low Dose Bevacizumab + Lomustine
    Bevacizumab 5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle. Lomustine starting dose of 75 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Documented from the date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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