Glioma, Glioma, Malignant, Recurrent Glioma
Conditions
Brief summary
The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.
Interventions
RADIATIONPRDR
Proton pulsed reduced dose rate (PRDR) technique, to a dose of 54 Gy in 30 fractions (treatments) with proton radiotherapy. Treatments will occur once per day on consecutive weekdays.
Sponsors
Baptist Health South Florida
Ion Beam Applications
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Karnofsky performance status ≥ 50 * Histologically-confirmed or radiographic evidence of recurrent / progressive glioma * Prior treatment with radiotherapy to a minimum dose of 45 Gy * At least 6 months or greater between completion of prior radiotherapy and enrollment in this study. If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria: 1. New areas of tumor outside the original radiotherapy fields as determined by the investigator. 2. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment. 3. Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment. * Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy * Must not be pregnant (positive pregnancy test) or breastfeeding. Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Highly effective and acceptable forms of contraception are: * Male condom plus spermicide * Cap plus spermicide * Diaphragm plus spermicide * Copper T * Progesterone T * Levonorgestrel-releasing intrauterine system (e.g., Mirena®) * Implants * Hormone shot or injection * Combined pill * Mini-pill * Patch Individuals who meet any of the following criteria will not need contraception: * Individuals assigned male at birth * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50 * Radiation-induced oophorectomy with last menses \> 1 year ago * Chemotherapy-induced menopause with \>1 year interval since last menses * Surgical sterilization (bilateral oophorectomy or hysterectomy)
Exclusion criteria
* Two or more courses of prior radiotherapy * Inability to undergo an MRI with contrast * Leptomeningeal evidence of recurrent disease * Multi-focal disease * Any other condition that may put a participant at higher risk, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 3 months | PFS is defined as the duration of time from treatment start to first progressive disease (PD), date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation. Response to treatment will be assessed using Response Assessment in Neuro-Oncology (RANO). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) | 2 years | The total number of AEs considered possibly, probably, or definitely related to proton PRDR as per the CTCAE v5.0. |
| Overall survival (OS) | 2 years | OS is defined as the duration of time from treatment start to date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation. |
| Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0 | 2 years | The number of CNS AEs considered possibly, probably, or definitely related to proton PRDR as per CTCAE v5.0 |
| Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) | 1 year | Symptoms will be assessed using the MDASI-BT, which is a 28-item questionnaire that asks about cancer symptoms and how the symptoms interfere with daily life. Each item is scored on a 0-10 scale (0 = best, 10 = worst), with a total score of 0-280, with a higher score indicating worse symptoms. |
| Quality of life (QOL) assessed by the EuroQOL 5-dimension, 5-level (EQ-5D-5L) | 1 year | QOL will be assessed using the EQ-5D-5L questionnaire. There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. There also is a visual analog scale asking about overall health that ranges from 0-100. Higher scores indicate better health and QOL. |
Countries
United States
Contacts
CONTACTRobert Press, M.D.
CONTACTKristy Reyes
PRINCIPAL_INVESTIGATORRobert Press, M.D.
Miami Cancer Institute at Baptist Health, Inc.
Outcome results
None listed