Clinical trial

Pilot Trial of Dose-Volume Constraints for Reirradiation of Recurrent Brain Tumors

Name

2015-0586

Description

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.

Trial arms

Trial start

2016-07-20

Estimated PCD

2025-07-01

Trial end

2025-07-01

Status

Active (not recruiting)

Treatment

Bevacizumab

Arms:

Arm II (conventional fractionation, bevacizumab)

Other names:

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

Quality-of-Life Assessment

Ancillary studies

Arms:

Arm I (conventional fractionation), Arm II (conventional fractionation, bevacizumab)

Other names:

Quality of Life Assessment

Radiation Therapy

Undergo radiation therapy with conventional fractionation

Arms:

Arm I (conventional fractionation), Arm II (conventional fractionation, bevacizumab)

Other names:

Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Size

Primary endpoint

Highest grade of central nervous system (CNS) necrosis

At 6 months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-01-03

1 organization

1 drug

1 indication

Organization

M.D. Anderson Cancer Center

Drug

Atezolizumab

Indication

Brain Neoplasm