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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
2015-0586
- SECONDARY ID:
NCI-2016-00536
- SECONDARY ID:
2015-0586
- NCT ID:
NCT02698254
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Bevacizumab | 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 | Arm II (conventional fractionation, bevacizumab) |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm I (conventional fractionation) | Experimental | 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 (conventional fractionation, bevacizumab) | Active Comparator | 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. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | N/A |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Highest grade of central nervous system (CNS) necrosis |
| Time Frame: | At 6 months |
| Safety Issue: | |
| 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. |
Secondary Outcome Measures
| Measure: | Incidence of acute and late toxicities |
| Time Frame: | Up to 3.5 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival (OS) time |
| Time Frame: | Up to 3.5 years |
| Safety Issue: | |
| Description: | Will be estimated by Kaplan-Meier method, and the relationship of OS to baseline covariates will be evaluated by Bayesian survival time regression. |
| Measure: | Progression-free survival (PFS) time |
| Time Frame: | Up to 3.5 years |
| Safety Issue: | |
| Description: | Will be estimated by Kaplan-Meier method, and the relationship of PFS to baseline covariates will be evaluated by Bayesian survival time regression. |
| Measure: | Quality of life |
| Time Frame: | Up to 3.5 years |
| Safety Issue: | |
| Description: | Will be assessed using the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and patient-reported outcomes measurement information system (PROMIS) instrument. |
| Measure: | Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI) |
| Time Frame: | Up to 3.5 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
January 7, 2021
