Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma

NCT03506139 | Withdrawn Phase 2 DMC FDA Device

• 1 other identifier: 201801819
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial increases radiation to areas of the brain considered to be at risk for cancer. The at-risk areas are identified by a biological MRI scan. The study will look at side effects of the radiation and overall survival.

Conditions

Glioblastoma; Glioblastoma Multiforme

Keywords

Radiotherapy; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Estimate 12-month overall survival of GBM patients treated with 75 Gray of radiation based on advanced MRI planning, with concurrent temozolomide.

  12 months after completing radiation therapy

Secondary Outcomes (4)

• Progression free survival (PFS)

  Every 2 months, for up to 60 months after completing radiation therapy, until progression or death from any cause

• Identifying tissue at risk of recurrence

  12 months after completing radiation therapy

• Distinguish progression from pseudoprogression

  12 months after completing radiation therapy

• Adverse events related to treatment

  Weekly during radiation therapy, every 2 months post-radiation therapy for 7 months, then 13 & 19 months post-radiation

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

External beam radiation therapy delivered to target volume.

Radiation: External beam radiation therapy

Interventions

External beam radiation therapy RADIATION

Radiotherapy to 75 Gy Radiation delivered 1 fraction / day, Monday through Friday, for a total of 30 fractions

Also known as: radiotherapy, radiation

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to provide informed consent
• Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma.
• Patients must be 18 years of age or older.≥
• Karnofsky performance status ≥ 70
• Minimal life expectancy of 12 weeks.
• Maximal contiguous volume of tumor based on high b-value diffusion MRI and perfusion MRI \< 1/3 volume of brain
• Patients must be treated within 6 weeks of most recent resection
• Within 21 days of radiation fraction 1, the following blood test parameters must be met:
• Hemoglobin ≥ 10 g/dL (transfusion is acceptable)
• absolute neutrophils ≥ 1500/mm3
• platelet count ≥ 100,000/mm3
• total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome)
• ALT and AST ≤ 5 x ULN
• serum creatinine ≤ 2.0 mg/dL

You may not qualify if:

• Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
• Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is \>3 years.
• Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination).
• Multifocal disease (\>1 lobe of involvement) of discontiguous, contrast enhancing disease as seen on conventional MRI
• Evidence of severe concurrent disease requiring treatment
• Known active malignancy as determined by treating medical and radiation oncologist
• Patients unable to undergo MRI exams
• Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring inpatient hospitalization or delay treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise subject safety.
• Pregnant women are excluded from this study because ionizing radiation is a known teratogen, and temozolomide is a Class D agent with the potential for teratogenic or abortifacient effects.
• Nursing mothers declining to discontinue breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with temozolomide.
• Patients with reproductive potential declining to use an effective contraceptive method during treatment are excluded from this study.

Sponsors & Collaborators

• John M. Buatti: lead
• Holden Comprehensive Cancer Center: collaborator

Study Sites (1)

University of Iowa Department of Radiation Oncology

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Hamstra DA, Galban CJ, Meyer CR, Johnson TD, Sundgren PC, Tsien C, Lawrence TS, Junck L, Ross DJ, Rehemtulla A, Ross BD, Chenevert TL. Functional diffusion map as an early imaging biomarker for high-grade glioma: correlation with conventional radiologic response and overall survival. J Clin Oncol. 2008 Jul 10;26(20):3387-94. doi: 10.1200/JCO.2007.15.2363. Epub 2008 Jun 9.

  PMID: 18541899 BACKGROUND

• Galban CJ, Chenevert TL, Meyer CR, Tsien C, Lawrence TS, Hamstra DA, Junck L, Sundgren PC, Johnson TD, Galban S, Sebolt-Leopold JS, Rehemtulla A, Ross BD. Prospective analysis of parametric response map-derived MRI biomarkers: identification of early and distinct glioma response patterns not predicted by standard radiographic assessment. Clin Cancer Res. 2011 Jul 15;17(14):4751-60. doi: 10.1158/1078-0432.CCR-10-2098. Epub 2011 Apr 28.

  PMID: 21527563 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• John M. Buatti, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & Chair, Department of Radiation Oncology

Model Details: Group treated to 75 Gray of radiation to at-risk target

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 23, 2018
• Study Start: May 15, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon request
• Access Criteria: Email study contacts with request

Locations

US (1)