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Anti-cancer Drug
ChemoID-Guided Therapy for Glioblastoma (CSCRGBM Trial)
Phase 3
Waitlist Available
Led By Tulika Ranjan, MD
Research Sponsored by Cordgenics, LLC
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 4, 6, 9, and 12 months
Awards & highlights
CSCRGBM Trial Summary
This trial will test whether a tumor's reaction to chemotherapy can predict how well a patient with a brain tumor will respond to the treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests whether a cancer stem cell test called ChemoID can predict how well patients respond to chemotherapy in recurrent glioblastoma. Participants will receive standard chemotherapy guided by the results of this test.See study design
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, and possible organ damage.
CSCRGBM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4, 6, 9, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 6, 9, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median Overall Survival (OS)
Secondary outcome measures
Median Progression Free Survival (PFS)
Objective Tumor Response
Overall Survival at 6, 9, and 12 Months (OS6mo, OS9mo, OS12mo)
+2 moreCSCRGBM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ChemoID-guided treatmentExperimental Treatment2 Interventions
Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list.
ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations:
Carboplatin;
Irinotecan;
Etoposide;
BCNU;
CCNU;
Temozolomide;
Procarbazine;
Vincristine;
Imatinib;
Procarbazine, CCNU, Vincristine;
Carboplatin, Irinotecan;
Carboplatin, Etoposide;
Temozolomide, Etoposide;
Temozolomide, Imatinib.
The treating physician will receive the ChemoID assay results from the ChemoID lab.
Group II: Physician Choice treatmentActive Control2 Interventions
Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list).
Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations:
Carboplatin;
Irinotecan;
Etoposide;
BCNU;
CCNU;
Temozolomide;
Procarbazine;
Vincristine;
Imatinib;
Procarbazine, CCNU, Vincristine;
Carboplatin, Irinotecan;
Carboplatin, Etoposide;
Temozolomide, Etoposide;
Temozolomide, Imatinib. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ChemoID assay
2018
Completed Phase 3
~80
Chemotherapy
2003
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
Cordgenics, LLCLead Sponsor
2 Previous Clinical Trials
450 Total Patients Enrolled
Tulika Ranjan, MDPrincipal InvestigatorAllegheny Health Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It is strongly advised not to use herbal supplements or tetrahydrocannabinol/cannabidiol (THC/CBD), but it is not strictly forbidden.You have recently been diagnosed with a type of brain cancer called GBM (glioblastoma).You are expected to live for at least 3 more months.Your tumor has come back after surgery and can be removed again.
Research Study Groups:
This trial has the following groups:- Group 1: Physician Choice treatment
- Group 2: ChemoID-guided treatment
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is ChemoID assay linked with any adverse health effects in people?
"ChemoID assay received a score of 3 because there is evidence from past clinical trials to support both its safety and efficacy."
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