ChemoID-Guided Therapy for Glioblastoma

(CSCRGBM Trial)

No longer recruiting at 13 trial locations

Overseen By Sara Ohm, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cordgenics, LLC

Disqualifiers: Newly diagnosed GBM, Pregnancy, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

Informed consent obtained and signed

In all cases, the diagnosis must be confirmed by a pathologist

Prior to surgery there was imaging evidence of measurable progressive disease (PD)

Exclusion Criteria

Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min)

Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry. Women of childbearing potential must practice medically approved contraceptive precautions

Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy treatment based on either standard-of-care chosen by the physician or guided by ChemoID assay results

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ChemoID assay
• Chemotherapy

Trial Overview

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.

How Is the Trial Designed?

Group I: ChemoID-guided treatment Experimental Treatment 2 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 treatment Active Control 2 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.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

Cordgenics, LLC

Lead Sponsor

Trials

3

Recruited

230+

Published Research Related to This Trial

Temozolomide, a key chemotherapy drug for glioblastoma, faces significant resistance primarily due to the activation of the O-6-methylguanine-DNA methyltransferase enzyme, which repairs the DNA damage caused by the drug, thus restoring genomic integrity.

Recent research has identified various mechanisms contributing to temozolomide resistance, including indirect DNA repair systems, drug efflux mechanisms, epigenetic changes, and influences from the tumor microenvironment, highlighting the complexity of overcoming this resistance in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide Resistance: A Multifarious Review on Mechanisms Beyond O-6-Methylguanine-DNA Methyltransferase. Rao, V., Kumar, G., Vibhavari, RJA., et al.[2023]

Malignant gliomas are challenging to treat, with surgery and radiation providing the most significant survival benefits, while chemotherapy offers only modest improvements.

The paper discusses the limited effectiveness of current chemotherapy agents and suggests that future treatments may rely on combination therapies that include both targeted biological compounds and traditional chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy in the treatment of malignant gliomas. Stern, JI., Raizer, JJ.[2007]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37137304/

Cancer stem cell assay-guided chemotherapy improves ...

In the ChemoID assay-guided group, median survival is 12.5 months (95% confidence interval [CI], 10.2-14.7) compared with 9 months (95% CI, 4.2- ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03632135

Study Details | NCT03632135 | Standard Chemotherapy vs ...

Cancer stem cell assay-guided chemotherapy improves survival of patients with recurrent glioblastoma in a randomized trial. Cell Rep Med. 2023 May 16;4(5): ...

3.

academic.oup.com

academic.oup.com/noa/article/5/1/vdad055/7160637

Treatment of unmethylated MGMT-promoter recurrent ...

The results presented here suggest that the ChemoID Assay can be used to individualize chemotherapy choices to improve poor-prognosis recurrent GBM patient ...

4.

asco.org

asco.org/abstracts-presentations/ABSTRACT152239

ChemoID assay for glioblastoma.

Results from the 11 GBM patients analyzed suggest that the prediction of chemosensitivity on primary cells was 100% sensitive, but only 50% specific with a ...

5.

digitalscholar.lsuhsc.edu

digitalscholar.lsuhsc.edu/som_facpubs/960/

"Cancer Stem Cell Assay-guided Chemotherapy Improves ...

In the ChemoID assay-guided group, median survival is 12.5 months (95% confidence interval [CI], 10.2–14.7) compared with 9 months (95% CI, 4.2– ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10213810/

Cancer stem cell assay-guided chemotherapy improves ...

Cancer stem cell assay-guided chemotherapy improves survival of patients with recurrent glioblastoma in a randomized trial

7.

nature.com

nature.com/articles/s41698-025-00874-0

ChemoID-guided therapy improves objective response rate ...

Real-world clinical studies demonstrated improved PFS and OS of recurrent EOC patients after treatment with cancer stem cell assay-guided ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S193652331930717X

Cancer Stem Cell Chemotherapeutics Assay for ...

Notably, patients with recurrent GBM or progressive high-grade glioma treated with assay-guided therapy had a 57% probability to survive at 12 months, compared ...

9.

withpower.com

withpower.com/trial/phase-3-glioblastoma-4-2018-83fb7

ChemoID-Guided Therapy for Glioblastoma ...

This trial tests if using the ChemoID test to choose chemotherapy drugs can improve outcomes for patients with recurrent glioblastoma (GBM)