Clinical trial NCT05393258: Temporally-modulated Pulsed Radiation Therapy (TMPRT) After Prior EBRT for Recurrent IDH-mutant Gliomas
Official title: A Pilot Study of Temporally-modulated Pulsed Radiation Therapy to Reirradiate Recurrent IDH-mutant Gliomas After Prior External Beam Radiation Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Astrocytoma
Oligodendroglioma, Adult
Glioma, Malignant
Keywords: IDH mutant glioma
astrocytoma
oligodendroglioma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial studies the side effects of temporally-modulated pulsed radiation therapy (TMPRT) in patients with IDH-mutant gliomas who have previously received radiation therapy to the brain. TMPRT is a radiation technique in which radiation is delivered in multiple small doses on a specific timed interval, instead of delivering one large dose at one time. This technique may improve efficacy while reducing toxicity and improving patient quality of life.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed recurrent IDH-mutant gliomas (either astrocytoma or oligodendroglioma) with prior external beam radiation therapy (EBRT) to the same region. The recurrent tumor may be either histologically confirmed or based on clinical assessment. Any number of prior recurrences is allowed.
* Maxium tumor diameter of 7 cm or less.
* Prior EBRT is ≥ 2 years ago.
* The region for reirradiation should have received at least 45 Gy from the prior EBRT but no more than 75 Gy. The prior EBRT could be either photon-based or proton-based.
* Prior SRS to the same region is permitted as long as the cumulative dose of EBRT plus SRS is no more than 75 Gy. The prior SRS should be completed at least 6 months ago.
* Life expectancy ≥ 12 months
* At least 18 years of age.
* Karnofsky performance status (KPS) of at least 70%.
* Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).

Exclusion Criteria:

* Leptomeningeal or metastatic involvement.
* Prior history of grade 3 or higher radiation necrosis that is at least possibly related to prior radiotherapy.
* Use of concurrent bevacizumab or other anti-VEGF-directed therapy during TMPRT is not allowed. If the patient is on bevacizumab, the patient needs to discontinue bevacizumab for at least 4 weeks prior to the start of TMPRT and remain stable. Other chemotherapy, immunotherapy, or target therapy can be used concurrently or adjuvantly at the discretion of treating physician.
* Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
* Pregnant.

Primary outcomes:
measure: Frequency of acute intolerable toxicities
timeFrame: From start of treatment through 3 months
measure: Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events
timeFrame: From start of treatment through 1 year
Secondary outcomes:
measure: Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
timeFrame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
measure: Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
timeFrame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
measure: Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)
timeFrame: Assessed at approximately 3 months, 6 months, and 12 months after start of treatment
measure: Progression-free survival (PFS)
timeFrame: At one year after start of treatment
measure: Overall survival (OS)
timeFrame: At one year after start of treatment
measure: Number of reirradiation adverse events
timeFrame: From start of treatment through month 12 follow-up
Other outcomes:
measure: Relative changes of different subtypes of myeloid cells
timeFrame: At baseline and week 6 of radiation therapy.
measure: Relative changes of different subtypes of circulating T-cells
timeFrame: At baseline and week 6 of radiation therapy.
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jiayi Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: