~6 spots leftby Jun 2027

Pulsed Radiotherapy for Brain Cancer

Palo Alto (17 mi)
Jiayi Huang, MD | Department of ...
Overseen byJiayi Huang, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Washington University School of Medicine
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.
Is the treatment TMPRT a promising treatment for brain cancer?Yes, TMPRT, also known as Pulsed Radiation Therapy, is promising for brain cancer because it shows effective tumor control and better protection of healthy tissue compared to standard radiotherapy.156810
What data supports the idea that Pulsed Radiotherapy for Brain Cancer is an effective treatment?The available research shows that Pulsed Radiotherapy (PRT) is effective in controlling tumors and protecting healthy tissue better than standard radiotherapy (SRT) in preclinical models and clinical series for glioblastoma, a type of brain cancer. Additionally, in a study comparing pulsed radiation with conventional radiation combined with a drug called temozolomide in a mouse model, PRT showed promise as a new treatment approach for glioblastoma. This suggests that PRT could be a more effective option for treating brain cancer compared to traditional methods.12678
Do I have to stop taking my current medications for the trial?The trial requires you to stop taking bevacizumab at least 4 weeks before starting TMPRT. Other medications like chemotherapy, immunotherapy, or targeted therapy can be continued or started during the trial, as decided by your doctor. The protocol does not specify about other medications, so check with your doctor.
What safety data exists for Pulsed Radiotherapy for Brain Cancer?The research provided does not directly address the safety data for Pulsed Radiotherapy for Brain Cancer, including TMPRT or Temporally-modulated Pulsed Radiation Therapy. However, one study evaluates pulsed low-dose radiation therapy (PLRT) combined with temozolomide in a murine model of glioblastoma multiforme, which may offer some insights into its efficacy and potential safety profile. Other studies focus on different radiation therapies and temozolomide, highlighting common side effects such as neutropenia, anemia, and fatigue, but do not specifically address the safety of pulsed radiotherapy in humans.23479

Eligibility 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 am using or willing to use birth control during the study.
I am able to care for myself but may not be able to do active work.
I am 18 years old or older.

Exclusion Criteria

My cancer has spread to the lining of my brain or other parts of my body.
I have had severe tissue damage from radiation therapy before.

Treatment Details

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

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.
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.
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.
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).
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).
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).
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.