Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05284643
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Intensity Modulated Proton Therapy (IMPT) — RADIATION
    Participants will receive radiation therapy delivered via intensity modulated proton therapy (IMPT) simultaneous integrated boost technique over a period of 10 days, 5 days per week for approximately 2 weeks.
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously (IV), beginning at a dose of 10 mg/kg every 2-3 weeks until disease progression.

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Jul 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: sMRI-Guided RT at 35 Gy in 10 fractions
    Participants will receive a total dose of 3500 centigrays (cGY) (35Gy) of Spectroscopic Magnetic Resonance Imaging (sMRI)-guided radiation therapy delivered in 10 fractions, 350 cGy (3.5 Gy) to the Clinical Target Volume (CTV) by Intensity Modulated Proton Therapy (IMPT) simultaneous integrated boost technique. Participants will also receive Bevacizumab per standard of care, at treating physician's discretion. Initial dose will begin prior to first dose of radiation therapy (RT).
  • Experimental: Cohort B: sMRI-Guided RT at 40 Gy in 10 fractions
    Participants will receive a total dose of 4000 cGY (40Gy) of Spectroscopic Magnetic Resonance Imaging (sMRI)-guided radiation therapy delivered in 10 fractions, 400 cGy (4 Gy) to the Clinical Target Volume (CTV) by Intensity Modulated Proton Therapy (IMPT) simultaneous integrated boost technique. Participants will also receive Bevacizumab per standard of care, at treating physician's discretion. Initial dose will begin prior to first dose of radiation therapy (RT).

Primary Outcome Measure

Percentage of patients for whom sMRI-guided therapy is technically successful [ Time Frame: About 60 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Zuzel Rodriguez
[email protected]
305-243-0124
Jonathan Bell, MD, PhD
[email protected]
305-689-0153
Jonathan Bell, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Miami· Miami, FL

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