CompletedNCT03632135CSCRGBMUpdated Apr 15, 2025Results posted

Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma

A Phase 3 interventional study of ChemoID assay and Chemotherapy in Recurrent Glioblastoma, sponsored by Cordgenics, LLC. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by Cordgenics, LLC · Phase 3, Interventional, and Diagnostic

Phase: Phase 3
Study type: Interventional
Enrollment: 78
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this clinical study is to confirm the utility of chemosensitivity tumor testing on cancer stem cells (ChemoID) as a predictor of clinical response in poor prognosis malignant brain tumors such as recurrent glioblastoma (GBM).

Read the detailed description

This study is designed as a parallel group randomized controlled clinical trial to determine if recurrent Glioblastoma (GBM) patients treated with drugs predicted by the ChemoID assay will have better outcomes than patients treated with standard-of-care control therapy chosen by the Physician.

Upon obtaining informed consent, all eligible participants affected by recurrent GBM will have a tumor biopsy to undergo ChemoID drug response testing with multiple FDA-approved chemotherapeutic agents.

Eligible participants will be randomized to a standard treatment arm with control treatment (chemotherapy chosen by the Physician from a provided list), or to a study arm of FDA-approved drugs selected by the ChemoID drug response assay.

Conditions studied

Recurrent Glioblastoma

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Keywords

ChemoID
Cancer stem cells
Drug response assay
Glioblastoma
Brain Cancer

In context

Glioblastoma

1,921 studies on the registry are indexed under Glioblastoma; 451 are open to participants now.

This study's enrollment of 78 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Cordgenics, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Men and Women and members of all ethnic groups who are at least 18 years old at the time of enrollment are eligible for this trial;
Informed consent obtained and signed;
Willing and able to commit to study procedures including long-term follow-up visit(s);
Histopathologically confirmed 2016-WHO grade III recurrent glioma, and grade IV recurrent glioblastoma (GBM), inclusive of Gliosarcoma
In all cases, the diagnosis must be confirmed by a pathologist.
Recurrent surgically resectable tumor and/or biopsy;
Participants who have undergone surgical resection should have received an MRI or a scan after surgery in order to visualize residual tumor. If not, the operative report must be available;
Prior to surgery there was imaging evidence of measurable progressive disease (PD);
Start of radiotherapy, if indicated, must occur at least 2 weeks after surgery and/or biopsy;
Estimated survival of at least 3 months;
Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platelets > 100,000; Creatinine \< 1.5 times the upper limit of laboratory normal value; Bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \< 3 times the upper limit of laboratory normal value;
If indicated radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy.
Bevacizumab (Avastin) is allowed. If indicated it should be initiated at least 4 weeks post craniotomy or biopsy if the wound has healed well without any drainage or cellulitis;
The use of herbal preparation or tetrahydrocannabinol/cannabidiol is strongly discouraged, but not contraindicated;

Exclusion criteria

Exclusion Criteria:

Subjects with newly diagnosed GBM
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
Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
Patient unable to follow procedures, visits, examinations described in the study;
Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);
History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer, any time prior to screening, are eligible;
OPTUNE device is not permitted in the study;
Patients cannot participate to any clinical trials utilizing a liquid biomarker or imaging studies that impact the overall survival.

Study design

Phase: Phase 3
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 78 participants (actual)

Study arms

Active comparator
Physician Choice treatment
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.
Diagnostic Test: ChemoID assay · Drug: Chemotherapy
Experimental
ChemoID-guided treatment
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.
Diagnostic Test: ChemoID assay · Drug: Chemotherapy

Interventions

Diagnostic testChemoID assay
The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses a patient's live tumor cells to indicate which chemotherapy agent (or combinations) will kill not only bulk of tumor cells, but importantly the cancer stem cells (CSCs) that are known to cause cancer to recur. During the assay, cancer stem cells and bulk tumor cells from an individual patient are exposed to FDA-approved chemotherapy drugs. The test measures the cytotoxic effect of actual doses of standard-of-care chemotherapies. The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse.
DrugChemotherapy
Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent high-grade glioma
Also known as: Cytotoxic chemotherapy drugs

What researchers measure

Primary outcomes

Median Overall Survival (OS)
Overall survival (OS) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.
Time frame: 36 months

Secondary outcomes

Median Progression Free Survival (PFS)
Median Progression Free Survival in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.
Time frame: 36 months

Results

Posted Nov 30, 2023

Participant flow

Participant flow — Overall Study
Milestone	Physician Choice Treatment	ChemoID-guided Treatment
Started	35	43
Completed	35	43
Not completed	0	0

Outcome measures

PrimaryMedian Overall Survival (OS)

Overall survival (OS) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.

Time frame:: 36 months
Reported as:: Median · months

Median Overall Survival (OS)
months	Physician Choice Treatment	ChemoID-guided Treatment
Median Overall Survival (OS)	7.5 (3.5 to 11.5)	12 (10.8 to 13.2)

SecondaryMedian Progression Free Survival (PFS)

Median Progression Free Survival in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.

Time frame:: 36 months
Reported as:: Median · months

Median Progression Free Survival (PFS)
months	Physician Choice Treatment	ChemoID-guided Treatment
Median Progression Free Survival (PFS)	3.5 (1.9 to 5.1)	10.1 (4.8 to 15.4)

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Physician Choice Treatment	35/35 (100%)	12/35 (34.3%)	6/35 (17.1%)
ChemoID-guided Treatment	43/43 (100%)	18/43 (41.9%)	5/43 (11.6%)

Most frequent serious events

Most frequent serious events
Event	Physician Choice Treatment	ChemoID-guided Treatment
Low White blood cell countBlood and lymphatic system disorders	8/35	9/43
Low platelet countBlood and lymphatic system disorders	7/35	4/43
ALT increasedHepatobiliary disorders	1/35	1/43
AnemiaBlood and lymphatic system disorders	1/35	1/43
Muscle WeaknessMusculoskeletal and connective tissue disorders	1/35	1/43
DiarrheaGastrointestinal disorders	0/35	1/43
ThromboemboliaVascular disorders	0/35	1/43

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Physician Choice Treatment	ChemoID-guided Treatment
Low white blood cells countBlood and lymphatic system disorders	3/35	2/43
FatigueGeneral disorders	3/35	1/43
Platelet count decreasedBlood and lymphatic system disorders	2/35	3/43
NeuropathyNervous system disorders	2/35	2/43
ConstipationGastrointestinal disorders	1/35	2/43
NauseaGeneral disorders	1/35	1/43
AnorexiaGeneral disorders	1/35	1/43
weight lossGeneral disorders	1/35	1/43
SeizureNervous system disorders	1/35	1/43
weaknessGeneral disorders	1/35	1/43

Baseline characteristics

subjects affected by recurrent GBM

Age, Categorical
Age, Categorical(Participants)	Physician Choice Treatment	ChemoID-guided Treatment	Total
<=18 years	0	0	0
Between 18 and 65 years	10	5	15
>=65 years	25	38	63

Age, Continuous
Age, Continuous(years)	Physician Choice Treatment	ChemoID-guided Treatment	Total
Median	55 ± 11	61 ± 13	59 ± 12.0

Sex: Female, Male
Sex: Female, Male(Participants)	Physician Choice Treatment	ChemoID-guided Treatment	Total
Female	14	15	29
Male	21	28	49

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Physician Choice Treatment	ChemoID-guided Treatment	Total
American Indian or Alaska Native	1	0	1
Asian	2	2	4
Native Hawaiian or Other Pacific Islander	0	3	3
Black or African American	1	0	1
White	31	36	67
More than one race	0	2	2
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Physician Choice Treatment	ChemoID-guided Treatment	Total
United States	35	43	78

Study locations

13 sites

Kaiser Permanente
Los Angeles, California 90027, United States
Keck School of Medicine of the University of Southern California
Los Angeles, California 90033, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana 70112, United States
Maine Medical Center Research Institute
Scarborough, Maine 04074, United States
University of Mississippi Medical Center
Jackson, Mississippi 39216, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio 45267, United States
Toledo University
Toledo, Ohio 43614, United States
Providence Cancer Center Oncology
Portland, Oregon 97225, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015, United States
The Penn State Univeristy College of Medicine
Hershey, Pennsylvania 17033, United States
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania 19104, United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15212, United States
Charleston Area Medical Center
Charleston, West Virginia 25326, United States

References and documents

Publications

Howard CM, Valluri J, Alberico A, Julien T, Mazagri R, Marsh R, Alastair H, Cortese A, Griswold M, Wang W, Denning K, Brown L, Claudio PP. Analysis of Chemopredictive Assay for Targeting Cancer Stem Cells in Glioblastoma Patients. Transl Oncol. 2017 Apr;10(2):241-254. doi: 10.1016/j.tranon.2017.01.008. Epub 2017 Feb 12. PubMed 28199863 ↗
Ranjan T, Howard CM, Yu A, Xu L, Aziz K, Jho D, Leonardo J, Hameed MA, Karlovits SM, Wegner RE, Fuhrer R, Lirette ST, Denning KL, Valluri J, Claudio PP. Cancer Stem Cell Chemotherapeutics Assay for Prospective Treatment of Recurrent Glioblastoma and Progressive Anaplastic Glioma: A Single-Institution Case Series. Transl Oncol. 2020 Apr;13(4):100755. doi: 10.1016/j.tranon.2020.100755. Epub 2020 Mar 17. PubMed 32197147 ↗
Ranjan T, Yu A, Elhamdani S, Howard CM, Lirette ST, Denning KL, Valluri J, Claudio PP. Treatment of unmethylated MGMT-promoter recurrent glioblastoma with cancer stem cell assay-guided chemotherapy and the impact on patients' healthcare costs. Neurooncol Adv. 2023 May 12;5(1):vdad055. doi: 10.1093/noajnl/vdad055. eCollection 2023 Jan-Dec. PubMed 37287692 ↗
Ranjan T, Sengupta S, Glantz MJ, Green RM, Yu A, Aregawi D, Chaudhary R, Chen R, Zuccarello M, Lu-Emerson C, Moulding HD, Belman N, Glass J, Mammoser A, Anderson M, Valluri J, Marko N, Schroeder J, Jubelirer S, Chow F, Claudio PP, Alberico AM, Lirette ST, Denning KL, Howard CM. 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):101025. doi: 10.1016/j.xcrm.2023.101025. Epub 2023 May 2. PubMed 37137304 ↗

Study documents

Protocol, analysis plan and consent form · Jan 4, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03632135
Lead sponsor: Cordgenics, LLC
Responsible party: Sponsor
First posted: Aug 15, 2018
Start date: May 20, 2018
Primary completion: Jun 16, 2022
Completion: Dec 31, 2023
Results posted: Nov 30, 2023
Last update: Apr 15, 2025

Study contacts

Tulika Ranjan, MD

principal investigator · Allegheny Health Network

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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