Glioblastoma Clinical Trial
Official title:
Prospective, Randomized Controlled Trial of Surgical Resection Prior to Bevacizumab Therapy for Recurrent Glioblastoma Multiforme
Background:
- Glioblastoma (GBM) is the most common malignant brain tumor in adults. Patients with GBM
are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most
GBMs start growing again. Bevacizumab, a chemotherapy drug, has shown promise in slowing the
growth of GBMs. More research is needed to find out whether having surgery before starting
bevacizumab is more effective than bevacizumab alone.
Objectives:
- To compare surgery plus bevacizumab to bevacizumab alone in adults with glioblastoma.
Eligibility:
- Individuals at least 18 years old whose glioblastoma has come back after treatment.
Design:
- All participants will be screened with a physical exam, medical history, blood tests,
and imaging studies.
- Participants will be divided into two groups. One group will have surgery followed by
bevacizumab. The other group will have the drug without surgery.
- The first group will have surgery as soon as possible and will begin bevacizumab 4 weeks
after surgery. The second group will start the drug as soon as possible.
- Both groups will receive the drug as an infusion every 2 weeks. They will be monitored
with frequent blood tests and imaging studies. The infusions will continue for as long
as the drug is effective at preventing tumor regrowth.
- Participants will be contacted every 4 weeks after they stop taking bevacizumab. They
will answer followup questions either in person or by telephone.
Objective
The objective of this prospective randomized controlled study is to determine the overall
survival benefit of tumor resection in patients with recurrent glioblastoma multiforme (GBM).
Study Population
This study will recruit 42 adults with a diagnosis of recurrent grade 4 astrocytoma into each
of two arms, for a total of 84 patients. All participants will be good candidates for
elective surgical resection of their tumors according to the previously established NIH
Recurrent Glioma Scale (NRGS), which uses performance status, tumor volume, and tumor
involvement of critical/eloquent brain areas as prognostic criteria. Patients who require
biopsy only or have previously been treated with bevacizumab will be excluded.
Design
Participants will be stratified by NRGS score (NRGS 0 or NRGS 1-2) and randomized to surgery
followed by bevacizumab or to bevacizumab alone. Patients assigned to the surgical arm will
undergo their procedure within 28 days of randomization. Treatment with bevacizumab at a dose
of 10 mg/kg every 2 weeks will begin at least 28 days later to allow adequate craniotomy
wound healing. Patients assigned to the non-surgical arm will start bevacizumab at a dose of
10 mg/kg every 2 weeks immediately. MRI evaluations will take place within 72 hours of
surgery to assess extent of resection, 28 days postoperatively, 96 hours after starting
bevacizumab, and then every 28 days until tumor progression is documented. Follow-up
assessments will take place every 28 days while on bevacizumab until tumor progression. Once
progression is established, patients will be free to pursue further surgical and/or medical
salvage therapy as they wish. Patients will be followed until their time of death.
Outcome Measures
The primary outcome measure is median overall survival from the date bevacizumab is started.
Secondary outcome measures include the rate of progression-free survival 6 months after
starting bevacizumab, median progression-free survival, overall survival rates at 6 and 12
months after starting bevacizumab, objective response rate, health-related quality of life,
change in KPS of 20 points or more, time to need for additional tumor therapy, and use of
corticosteroids.
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