Pulsed Radiotherapy for Brain Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Must not be taking: Bevacizumab, Anti-VEGF
Disqualifiers: Leptomeningeal, Metastatic, Radiation necrosis, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial studies the side effects of a new method of giving radiation in small, timed doses, in patients with certain types of brain tumors who have had earlier treatments. This approach may be more effective and less harmful.
Will I have to stop taking my current medications?
The trial requires you to stop taking bevacizumab (a medication used to treat certain types of cancer) at least 4 weeks before starting the study. Other medications like chemotherapy or immunotherapy can be continued, but it's best to discuss with your doctor.
What data supports the effectiveness of the treatment TMPRT for brain cancer?
Research shows that pulsed radiation therapy (PRT) can effectively control tumors and protect normal tissue better than standard radiotherapy in brain cancer models. Additionally, combining pulsed radiation with drugs like temozolomide has shown promising results in treating resistant brain tumors in animal studies.
12345Is pulsed radiotherapy generally safe for humans?
There is limited safety data specifically on pulsed radiotherapy for brain cancer in humans, but related treatments like temozolomide with radiation therapy have shown some side effects such as fatigue, nausea, and blood-related issues. Severe side effects are rare, but they can include significant blood problems.
35678How is the treatment TMPRT different from other treatments for brain cancer?
TMPRT (Temporally-modulated Pulsed Radiation Therapy) is unique because it delivers radiation in pulses, which has shown to effectively control tumors while better sparing normal tissue compared to standard radiotherapy. This approach is being investigated for its potential benefits in treating newly diagnosed glioblastoma, a type of aggressive brain cancer.
1291011Eligibility Criteria
This trial is for adults with IDH-mutant gliomas (brain tumors) who've had prior radiation. They should have a life expectancy of over a year, be able to consent, and women must use birth control. It's not for pregnant individuals or those with certain medical conditions that conflict with the treatment.Inclusion Criteria
I had targeted radiation to the same area before, but the total dose was under 75 Gy and it was over 6 months ago.
I am using or willing to use birth control during the study.
I had external beam radiation therapy over 2 years ago.
+6 more
Exclusion Criteria
You are currently pregnant.
I am not using bevacizumab or similar drugs for my treatment.
My cancer has spread to the lining of my brain or other parts of my body.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive temporally-modulated pulsed radiation therapy (TMPRT) daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions.
6 weeks
Daily visits for radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and symptom burden.
12 months
Assessments at 3, 6, and 12 months
Participant Groups
The study tests TMPRT, a type of radiotherapy given in small doses at set intervals to potentially increase effectiveness and reduce side effects compared to one large dose. The focus is on patients who've previously received brain radiation therapy.
1Treatment groups
Experimental Treatment
Group I: Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)Experimental Treatment1 Intervention
Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
References
Pulsed radiation therapy for the treatment of newly diagnosed glioblastoma. [2021]Pulsed radiation therapy (PRT) has shown effective tumor control and superior normal-tissue sparing ability compared with standard radiotherapy (SRT) in preclinical models and retrospective clinical series. This is the first prospective trial to investigate PRT in the treatment of patients with newly diagnosed glioblastoma (GBM).
Short course radiotherapy is an appropriate option for most malignant glioma patients. [2019]To determine whether a shortened course of radiotherapy (RT) is an appropriate treatment option for malignant glioma patients.
Pulsed versus conventional radiation therapy in combination with temozolomide in a murine orthotopic model of glioblastoma multiforme. [2022]To evaluate the efficacy of pulsed low-dose radiation therapy (PLRT) combined with temozolomide (TMZ) as a novel treatment approach for radioresistant glioblastoma multiforme (GBM) in a murine model.
Pulsed Radiation Therapy With Concurrent Cisplatin Results in Superior Tumor Growth Delay in a Head and Neck Squamous Cell Carcinoma Murine Model. [2022]To assess the efficacy of 3-week schedules of low-dose pulsed radiation treatment (PRT) and standard radiation therapy (SRT), with concurrent cisplatin (CDDP) in a head and neck squamous cell carcinoma xenograft model.
Intensity-modulated radiation therapy combined with concomitant temozolomide for brain metastases from lung adenocarcinoma. [2020]Short-term efficacy, adverse effects and the impact on quality of life (QoL) of a concomitant treatment with intensity-modulated radiation therapy (IMRT) and temozolomide (TMZ) in patients with brain metastases (BMs) from lung adenocarcinoma were evaluated. This study sought to confirm the benefit of adding TMZ to IMRT in patients with BMs from lung adenocarcinoma. Nine patients were enrolled and received a dose of 30 Gy in 10 daily fractions to clinical tumor volume (CTV) according to IMRT, then additional dose of 9 Gy in 3 fractions of IMRT was delivered to gross tumor volume (GTV) only with concomitant TMZ (75 mg/m2/day) orally during RT for 3 weeks. One patient achieved complete response (CR) (11.1%), 6 patients obtained partial response (PR) (66.7%), and there were no patients in progression. Therefore, objective response (OR) reached 77.8%. The main adverse effects included neutropenia, anemia, vomiting, fatigue and dizziness. Grade ≥3 of hematologic toxicities did not occur. However, the other 9 patients who received only intensity-modulated radiation had much worse results. The CR was 0, PR rate was 44.4%, OR rate was 44.4%. The results indicated that the benefit of adding TMZ to IMRT was confirmed in patients with BMs from lung adenocarcinoma. The treatment was active, a significant OR was observed, and achieved an improvement in QoL demonstrated by QoL grade (p<0.05).
Clinical and Genetic Factors Associated With Severe Hematological Toxicity in Glioblastoma Patients During Radiation Plus Temozolomide Treatment: A Prospective Study. [2018]Temozolomide (TMZ) administered daily with radiation therapy (RT) for 6 weeks, followed by adjuvant TMZ for 6 cycles, is the standard therapy for newly diagnosed glioblastoma (GBM) patients. Although TMZ is considered to be a safe drug, it has been demonstrated to cause severe myelotoxicity; in particular, some case reports and small series studies have reported severe myelotoxicity developing during TMZ and concomitant RT. We performed a prospective study to analyze the incidence of early severe myelotoxicity and its possible clinical and genetic factors.
Proton and carbon ion radiotherapy for primary brain tumors and tumors of the skull base. [2016]To analyze clinical concepts, toxicity and treatment outcome in patients with brain and skull base tumors treated with photons and particle therapy.
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]Temozolomide (TMZ) is an oral alkylating agent principally indicated for neurological malignancies including glioblastoma (GBM) and astrocytoma. Most common side effects are mild to moderate, and include fatigue, nausea, vomiting, thrombocytopenia and neutropenia. Severe or prolonged myelosuppression, causing delayed treatment or discontinuation, is uncommon. Major haematological adverse effects such as myelodysplastic syndrome or aplastic anaemia (AA) have rarely been reported.
Proton radiotherapy for glioma and glioblastoma. [2023]Radiotherapy (RT) continues to be an important component of treatment of glioma, particularly high-grade glioma and glioblastoma multiforme (GBM). GBM is one of the most aggressive central nervous system (CNS) tumors, with high rates of recurrence and very low rates of long-term survival. However, outcomes in these patients are improving with modern genetic profiling and multimodal therapy, which leads to more consideration for the risk for toxicities associated with traditional photon-based RT. Proton therapy (PT) is an increasingly available method to reduce off-target irradiation in CNS tumors due to the intrinsic properties of heavy-particle irradiation. Here, we review currently available data examining the used of PT in glioma patients, including dose escalation for GBM, re-irradiation (reRT) of recurrent glioma, and the potential cognitive sparing effects of conventional dose PT. We discuss the incorporation of PT into the multimodal therapy of GBM patients, and how the aggressive nature of the disease poses a unique challenge to PT study design. We also describe how PT may provide the most feasible method for implementing high rate 'FLASH' RT and the implications for glioma patients. We conclude with a discussion of ongoing clinical trials, the necessity of continued research, and how we interpret and incorporate available data into our current practice.
Evaluating changes in radiation treatment volumes from post-operative to same-day planning MRI in High-grade gliomas. [2021]Adjuvant radiation therapy (RT) with temozolomide (TMZ) is standard of care for high grade gliomas (HGG) patients. RT is commonly started 3 to 5 weeks after surgery. The deformation of the tumor bed and brain from surgery to RT is poorly studied. This study examined the magnitude of volume change in the postoperative tumor bed and the potential impact of RT planning.
The Effects of Pulsed Radiation Therapy on Tumor Oxygenation in 2 Murine Models of Head and Neck Squamous Cell Carcinoma. [2022]To evaluate the efficacy of low-dose pulsed radiation therapy (PRT) in 2 head and neck squamous cell carcinoma (HNSCC) xenografts and to investigate the mechanism of action of PRT compared with standard radiation therapy (SRT).