Radiation for Glioblastoma

Cedars-Sinai Medical Center, Los Angeles, CA
Glioblastoma+1 More ConditionsRadiation - Radiation
All Sexes

Study Summary

This trial will study the effects of adding a new drug, BPM31510, to standard radiation and chemotherapy treatment for newly diagnosed glioblastoma patients.

Eligible Conditions
  • Glioblastoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 5 years

28 days post treatment
Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).
5 years
Efficacy will be assessed by subject Overall survival
6 months
Efficacy will be assessed by subject progression free survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

BPM31510, Vitamin K1, RT and TMZ
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Radiation · No Placebo Group · Phase 2

BPM31510, Vitamin K1, RT and TMZExperimental Group · 4 Interventions: Temozolomide (TMZ), Radiation, BPM31510, Vitamin K1 · Intervention Types: Drug, Radiation, Drug, Other
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Berg, LLCLead Sponsor
12 Previous Clinical Trials
2,189 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are allergic to CoQ10.
You have had an allergic reaction to Vitamin K1 when taken by mouth, injection, or under the skin.

Frequently Asked Questions

Has the FDA cleared radiation for use in treatment?

"The safety of radiation is estimated to be a 2. This is due to the fact that this is a phase 2 trial, which only provides some data supporting safety and no efficacy." - Anonymous Online Contributor

Unverified Answer

What conditions are often treated with Radiation?

"Radiation is commonly used to treat patients with nitrosourea treatment. However, it can also be employed to ameliorate other conditions such as refractory neuroblastoma, mycosis fungoides, and advanced directives." - Anonymous Online Contributor

Unverified Answer

Has there been anything like this experiment done before?

"Radiation has been studied since 2002, with the first clinical trial sponsored by Schering-Plough. After this initial study involving 60 patients, Radiation received Phase 2 drug approval and today there are 218 active studies taking place in 947 cities across 36 countries." - Anonymous Online Contributor

Unverified Answer

How many people can join this research project?

"Yes, the data on clinicaltrials.gov indicates that this clinical trial is presently recruiting candidates. The study was first posted on 8/2/2021 and was last edited on 5/31/2022. The study is enrolling 50 participants at 3 locations." - Anonymous Online Contributor

Unverified Answer

Are researchers looking for more trial participants at this time?

"The answer is affirmative, as the clinical trial in question is actively recruiting patients according to the information provided on clinicaltrials.gov. This specific trial was first posted on 8/2/2021 and has been edited most recently on 5/31/2022. There are plans to admit 50 individuals at 3 distinct locations." - Anonymous Online Contributor

Unverified Answer

What other scientific papers have been published on the topic of Radiation?

"There are currently 218 clinical trials underway that focus on research surrounding the use of radiation as a treatment. Of those, 25 have reached Phase 3. These numerous trials originate from 4820 locations with the majority being based in Seoul and Songpa." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.