← Back to Search

External Beam Radiation Therapy for Glioblastoma

Phase 2
Waitlist Available
Led By Ian F Parney
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing pembrolizumab in combination with standard therapy (temozolomide and radiation therapy) to see if it can help treat patients with glioblastoma by killing tumor cells.

Eligible Conditions
  • Glioblastoma
  • Gliosarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLT) (Group 1)
Overall survival (OS) (Group 2)
Secondary outcome measures
Incidence of adverse events
Progression-free survival (Group 2)
Time to progression (Group 2)
+4 more
Other outcome measures
Biomarkers

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2 (pembrolizumab, temozolomide, radiation therapy )Experimental Treatment5 Interventions
CONCURRENT (CYCLE 1): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLES 2-6): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 of cycles 2-5 and 1 and 22 of cycle 6 (up to a total of 17 doses). Patients also receive temozolomide PO daily on days 1-5, 29-33, and 57-61 of cycles 2 and 6, days 22-26 and 50-54 of cycle 3, days 15-19 and 43-47 of cycle 4, days 8-12 and 36-40 of cycle 5. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
Group II: Group 1 (pembrolizumab, surgery, temozolomide, radiation)Experimental Treatment6 Interventions
NEOADJUVANT (CYCLE 1): Patients receive pembrolizumab IV over 30 minutes on day 1. SURGERY (CYCLE 2): Patients undergo standard of care surgery within days 4-7. CONCURRENT (CYCLE 3): Starting 21-35 days after surgery, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 8-54. Patients also undergo external beam radiation therapy every 5 days per week on days 8-54. ADJUVANT (CYCLE 4-8): Within 3-5 weeks after completing radiation therapy, patients receive pembrolizumab IV over 30 minutes on days 1, 22, and 43 and temozolomide PO daily on days 1-5 every 28 days. Treatment repeats every 63 days for up to 5 cycles in the absence of disease progression or unexpected toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Radiation Therapy
2017
Completed Phase 3
~7250
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Pembrolizumab
2017
Completed Phase 2
~2010
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,088 Total Patients Enrolled
14 Trials studying Glioblastoma
747 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,659 Previous Clinical Trials
40,924,637 Total Patients Enrolled
322 Trials studying Glioblastoma
23,063 Patients Enrolled for Glioblastoma
Ian F ParneyPrincipal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the cohort being studied in this experiment?

"Affirmative. The trial is still recruiting, as evidenced by the information hosted on clinicaltrials.gov; it was initiated in September of 2017 and its most recent update occurred on the 22nd day of September 2022. Aspiring participants must be among fifty people chosen from a single healthcare facility."

Answered by AI

Could you elaborate on other studies that have explored the effects of External Beam Radiation Therapy?

"At present, 1162 active clinical trials are researching External Beam Radiation Therapy. Of those ongoing studies, 146 have reached the Phase 3 stage. The majority of these investigations occur in Houston, TX but studies for this treatment can be located at 40443 sites worldwide."

Answered by AI

What are the major goals of this investigation?

"This trial spans from the initiation of therapy to death or 18 months, whichever comes first. Primary outcomes include incidence of dose-limiting toxicities while secondary objectives comprise time until any treatment related adverse event, time to treatment failure and overall incidence rate for said reactions. Additionally, Grade 3 or higher events possibly linked to medication will be evaluated along with hematologic toxicity (e.g., thrombocytopenia, neutropenia and leukopenia). Other analyses such as nonhematologic CTCAE grading and overall adverse event profiles by each dosage level/tumour type are exploratory in nature."

Answered by AI

Are there empty slots in this experiment available for volunteers?

"Affirmative. According to clinicaltrials.gov, this trial is recruiting participants as of September 22nd 2022; the posting was initially made on September 15th 2017. The team are seeking 50 patients from 1 dedicated medical centre for their research study."

Answered by AI

What safety measures are in place to protect patients undergoing External Beam Radiation Therapy?

"We evaluated the safety of External Beam Radiation Therapy as a 2, as it has been tested in Phase 2 trials. While there is some evidence for its security, efficacy data remains missing."

Answered by AI

What maladies can be addressed with External Beam Radiation Therapy?

"External Beam Radiation Therapy is an effective modality for treating malignant neoplasms, unresectable melanoma, and tumors possessing a high degree of microsatellite instability."

Answered by AI

Has this kind of clinical research been conducted before?

"Ever since its first trial in 2002, financed by Schering-Plough and involving 60 patients, External Beam Radiation Therapy has been the subject of intense research. To date, 1162 live trials are underway across 64 countries in 3082 cities worldwide which have resulted in Phase 2 drug approval for this therapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma
Ian F. Parney, M.D., Ph.D. 2017. "Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03197506.
~3 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top