Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma

Description

The purpose of this research is to find hidden cancer with an experimental magnetic resonance imaging (MRI) scan called spectroscopic magnetic resonance imaging (sMRI). That spectroscopic MRI scan will be used to increase the area of the brain receiving radiation and then the dose of radiation in attempt to kill more of the cancer. Proton radiotherapy and bevacizumab (Avastin) are used to minimize the possible side effects of this approach.

Conditions

Recurrent Glioblastoma

Study Overview

Study Details

Study overview

The purpose of this research is to find hidden cancer with an experimental magnetic resonance imaging (MRI) scan called spectroscopic magnetic resonance imaging (sMRI). That spectroscopic MRI scan will be used to increase the area of the brain receiving radiation and then the dose of radiation in attempt to kill more of the cancer. Proton radiotherapy and bevacizumab (Avastin) are used to minimize the possible side effects of this approach.

Pilot Trial of Spectroscopic MRI-guided, Dose-Escalated Proton Radiation Therapy and Bevacizumab for Recurrent Glioblastoma

Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma

Condition
Recurrent Glioblastoma
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. An area of MRI enhancement consistent with glioblastoma outside of the initial high dose radiation field.
  • 2. Biopsy or resection proven recurrent glioblastoma.
  • 3. Progressive glioblastoma based on advanced imaging (brain positron emission tomography (PET), perfusion MRI, or clinical MR Spectroscopy)
  • 1. For "marginal" or "out of field" radiation failures where at least half of the enhancing disease is outside of the prior high dose radiation field but there is field overlap, patients must have completed prior radiation at least four months or more prior to study treatment.
  • 2. For "in field" radiation failures where at least half of the enhancing disease is within the prior high dose radiation field, patients must have completed prior radiation at least six months or more prior to study treatment.
  • 1. 28 days or 5 half-lives, whichever is shorter, elapsed from the administration of any experimental agent prior to initiation of study treatment.
  • 2. 28 days elapsed from the administration of any prior cytotoxic agents except
  • 1. \[urine protein\]/\[urine creatinine\]: if both protein and creatinine are reported in mg/dL
  • 2. \[(urine protein) x0.088\]/\[urine creatinine\]: if urine creatinine is reported in mmol/L
  • 1. No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • 2. In-range international normalized ratio (INR) (typically 2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, within 21 days prior to registration
  • 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration.
  • 2. Transmural myocardial infarction within the last 6 months prior to registration.
  • 3. History of stroke or transient ischemic attack within 6 months prior to registration.
  • 4. Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.
  • 5. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • 6. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
  • 7. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function other than screening panel (Section 3.1) and coagulation parameters are not required for entry into this protocol.
  • 8. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Eric Mellon, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2029-09-30