MedTrace Logo

Bevacizumab With or Without Surgery for Adult Glioblastomas

NCT01413438 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-07-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Craniotomy

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • John K Park, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-15
Primary Completion
2013-09-26
Completion
2013-09-26

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413438 on ClinicalTrials.gov