ChemoID-Guided Therapy for Glioblastoma
(CSCRGBM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to guide chemotherapy for individuals with recurring glioblastoma, an aggressive brain cancer. Researchers aim to determine if a special test, called ChemoID, can predict patient responses to specific chemotherapy drugs. The trial includes two groups: one receives standard chemotherapy, while the other receives treatment guided by ChemoID test results. Individuals with recurrent glioblastoma and surgically removable tumors may be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, providing patients an opportunity to access potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, the use of herbal preparations or tetrahydrocannabinol/cannabidiol is strongly discouraged, but not completely prohibited.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the chemotherapy drugs used in ChemoID-guided treatments are already standard options for treating glioblastoma, a type of brain cancer. These drugs include Carboplatin, Irinotecan, Etoposide, and others. They are well-known and have been used in medical practice for some time.
One study found that patients who received ChemoID-guided chemotherapy had a 57% chance of living for at least 12 months. This suggests that most patients could handle the treatment well. Although the study did not focus on side effects, the survival rate indicates that the treatment was manageable for most people.
Current studies do not provide detailed information on side effects specifically linked to the ChemoID-guided approach. However, since these chemotherapy drugs are already approved by the FDA for other uses, their safety is well-understood. Doctors know the common side effects, which can include nausea, tiredness, and hair loss.
In summary, based on current research and existing knowledge of these chemotherapy drugs, ChemoID-guided chemotherapy appears to be a well-tolerated and promising treatment option.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ChemoID-guided therapy for glioblastoma because it personalizes chemotherapy treatment using a unique assay to identify the most effective drugs for each patient. Unlike traditional treatments where physicians select from a list of standard chemotherapy drugs, ChemoID provides specific insights from the lab to guide these choices, potentially improving outcomes by tailoring the treatment to the individual’s tumor characteristics. This approach aims to enhance the effectiveness of chemotherapy and reduce unnecessary exposure to less effective drugs.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
Research has shown that ChemoID-guided chemotherapy for glioblastoma can extend patient survival. In this trial, participants in the ChemoID-guided treatment arm will receive chemotherapy drugs selected based on ChemoID assay results, which help doctors choose the most effective drugs for each person's cancer. One study found that patients treated with ChemoID lived about 12.5 months on average, compared to about 9 months for those who received standard chemotherapy, the approach used in the Physician Choice treatment arm of this trial. This personalized approach aims to enhance chemotherapy effectiveness for difficult-to-treat brain tumors like glioblastoma. Early results suggest this method could be a promising way to extend life for patients with recurring glioblastoma.26789
Who Is on the Research Team?
Tulika Ranjan, MD
Principal Investigator
Allegheny Health Network
Are You a Good Fit for This Trial?
This trial is for adults with confirmed recurrent glioblastoma who can undergo surgery and have certain blood counts within normal ranges. They must not be pregnant, nursing, or have severe kidney issues, and should agree to use contraception if applicable. Those with other recent cancers or using the OPTUNE device are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive chemotherapy treatment based on either standard-of-care chosen by the physician or guided by ChemoID assay results
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ChemoID assay
- Chemotherapy
Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cordgenics, LLC
Lead Sponsor