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Radiation Therapy in Treating Patients With Recurrent Brain Tumors Who Have Undergone Previous Radiation Therapy

Primary Purpose

Recurrent Brain Neoplasm

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Quality-of-Life Assessment
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Brain Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous pathologic confirmation of a tumor treated with radiation to the brain completed at least 6 months prior to the start of planned reirradiation, except for patients with tumors that are routinely diagnosed without biopsy, including germinoma and optic pathway glioma; patients with a history of cranial irradiation for leukemia are eligible
  • Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day
  • Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation
  • Patient may not receive concurrent chemotherapy with reirradiation, other than temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist
  • Patient must have imaging findings within the last 3 months consistent with recurrent disease in the brain; pathologic diagnosis of recurrence is not required
  • Patient may undergo surgical resection prior to reirradiation
  • Dose-volume histogram data and cross-sectional imaging from previous radiation must be obtained; electronic dosimetry records in Digital Imaging and Communications in Medicine (DICOM) format from previous radiation are strongly preferred
  • Signed informed consent by patient and/or parents or legal guardian
  • Lansky/Karnofsky performance status score of 50-100

Exclusion Criteria:

  • Patients with recurrent diffuse intrinsic pontine glioma (DIPG)
  • Pregnancy

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (conventional fractionation)

Arm II (conventional fractionation, bevacizumab)

Arm Description

Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Highest grade of central nervous system (CNS) necrosis
The outcome will be categorized as (death within 6 months), (alive at month 6 with necrosis), (alive at month 6 without necrosis). The probabilities of these outcomes will be estimated using 95% posterior credible intervals assuming a Dirichlet (.33, .33, .33) prior.

Secondary Outcome Measures

Incidence of acute and late toxicities
Overall survival (OS) time
Will be estimated by Kaplan-Meier method, and the relationship of OS to baseline covariates will be evaluated by Bayesian survival time regression.
Progression-free survival (PFS) time
Will be estimated by Kaplan-Meier method, and the relationship of PFS to baseline covariates will be evaluated by Bayesian survival time regression.
Quality of life
Will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and patient-reported outcomes measurement information system (PROMIS) instrument.
Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI)

Full Information

First Posted
February 29, 2016
Last Updated
July 3, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02698254
Brief Title
Radiation Therapy in Treating Patients With Recurrent Brain Tumors Who Have Undergone Previous Radiation Therapy
Official Title
Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2016 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot clinical trial studies the side effects and best dose of radiation therapy in patients with brain tumors that have come back after previous treatment with radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in different ways may kill more tumor cells.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the rate of grade 3 or higher central nervous system (CNS) necrosis 6 months after reirradiation of the brain for recurrent tumor. SECONDARY OBJECTIVES: I. To evaluate acute and late toxicities of reirradiation. II. To evaluate longitudinal changes in symptom burden of patients undergoing reirradiation. III. To use Advanced Brain Tumor Imaging (ABTI) to evaluate changes in the brain after reirradiation, including progression, pseudoprogression, and radionecrosis. IV. To estimate progression-free survival (PFS) and overall survival (OS) following reirradiation. OUTLINE: Patients are assigned to 1 of 2 arms based on age. ARM I (Age 0-18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. ARM II (Age > 18 years): Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 month, then every 2 months for 1 year, then every 3 months for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Brain Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (conventional fractionation)
Arm Type
Experimental
Arm Description
Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (conventional fractionation, bevacizumab)
Arm Type
Active Comparator
Arm Description
Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar SCT501, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy with conventional fractionation
Primary Outcome Measure Information:
Title
Highest grade of central nervous system (CNS) necrosis
Description
The outcome will be categorized as (death within 6 months), (alive at month 6 with necrosis), (alive at month 6 without necrosis). The probabilities of these outcomes will be estimated using 95% posterior credible intervals assuming a Dirichlet (.33, .33, .33) prior.
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Incidence of acute and late toxicities
Time Frame
Up to 3.5 years
Title
Overall survival (OS) time
Description
Will be estimated by Kaplan-Meier method, and the relationship of OS to baseline covariates will be evaluated by Bayesian survival time regression.
Time Frame
Up to 3.5 years
Title
Progression-free survival (PFS) time
Description
Will be estimated by Kaplan-Meier method, and the relationship of PFS to baseline covariates will be evaluated by Bayesian survival time regression.
Time Frame
Up to 3.5 years
Title
Quality of life
Description
Will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and patient-reported outcomes measurement information system (PROMIS) instrument.
Time Frame
Up to 3.5 years
Title
Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI)
Time Frame
Up to 3.5 years
Other Pre-specified Outcome Measures:
Title
Symptom burden
Description
Will be measured by MDASI-BT questionnaire in adults and PROMIS short forms in children.
Time Frame
Up to 3.5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous pathologic confirmation of a tumor treated with radiation to the brain completed at least 6 months prior to the start of planned reirradiation, except for patients with tumors that are routinely diagnosed without biopsy, including germinoma and optic pathway glioma; patients with a history of cranial irradiation for leukemia are eligible Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day Multidisciplinary evaluation of the patient must be performed with a consensus recommendation for reirradiation Patient may not receive concurrent chemotherapy with reirradiation, other than temozolomide or bevacizumab given at the discretion of the treating neuro-oncologist Patient must have imaging findings within the last 3 months consistent with recurrent disease in the brain; pathologic diagnosis of recurrence is not required Patient may undergo surgical resection prior to reirradiation Dose-volume histogram data and cross-sectional imaging from previous radiation must be obtained; electronic dosimetry records in Digital Imaging and Communications in Medicine (DICOM) format from previous radiation are strongly preferred Signed informed consent by patient and/or parents or legal guardian Lansky/Karnofsky performance status score of 50-100 Exclusion Criteria: Patients with recurrent diffuse intrinsic pontine glioma (DIPG) Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L McGovern
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Radiation Therapy in Treating Patients With Recurrent Brain Tumors Who Have Undergone Previous Radiation Therapy

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