RECRUITING

Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-09-30

Study Completion:2029-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05284643

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Zuzel Rodriguez

CONTACT

305-243-0124

z.rodriguez1@med.miami.edu

Eric Mellon, MD, PhD

CONTACT

305-243-0139

eric.mellon@med.miami.edu

Principal Investigator

Eric Mellon, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30

Study Completion Date2029-09-30

Study Record Updates

Study Start Date2022-09-30

Study Completion Date2029-09-30

Terms related to this study

Keywords Provided by Researchers

Brain Cancer

Additional Relevant MeSH Terms

Recurrent Glioblastoma