Trial Outcomes & Findings for Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma (NCT NCT03632135)

NCT ID: NCT03632135

Last Updated: 2025-04-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 78 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2025-04-15

Participant Flow

Participant milestones

Measure	Physician Choice Treatment Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list). * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent GBM	ChemoID-guided Treatment Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent GBM
Overall Study STARTED	35	43
Overall Study COMPLETED	35	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Physician Choice Treatment n=35 Participants Participants will be treated with standard-of-care chemotherapy chosen by the Physician from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent Glioblastoma	ChemoID-guided Treatment n=43 Participants Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent Glioblastoma	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants	38 Participants n=7 Participants	63 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=5 Participants	61 years STANDARD_DEVIATION 13 • n=7 Participants	59 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	28 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	36 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	43 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Predetermined interim analysis

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

Outcome measures

Measure	Physician Choice Treatment n=35 Participants Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list). * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent GBM	ChemoID-guided Treatment n=43 Participants Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent GBM
Median Overall Survival (OS)	7.5 months Interval 3.5 to 11.5	12 months Interval 10.8 to 13.2

SECONDARY outcome

Timeframe: 36 months

Population: final analysis

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

Outcome measures

Measure	Physician Choice Treatment n=35 Participants Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list). * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent GBM	ChemoID-guided Treatment n=43 Participants Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent GBM
Median Progression Free Survival (PFS)	3.5 months Interval 1.9 to 5.1	10.1 months Interval 4.8 to 15.4

Adverse Events

Physician Choice Treatment

Serious events: 12 serious events

Other events: 6 other events

Deaths: 35 deaths

ChemoID-guided Treatment

Serious events: 18 serious events

Other events: 5 other events

Deaths: 43 deaths

Serious adverse events

Measure	Physician Choice Treatment n=35 participants at risk Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list). * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent glioblastoma	ChemoID-guided Treatment n=43 participants at risk Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent glioblastoma
Blood and lymphatic system disorders Low White blood cell count	22.9% 8/35 • Number of events 22 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	20.9% 9/43 • Number of events 12 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Blood and lymphatic system disorders Low platelet count	20.0% 7/35 • Number of events 7 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	9.3% 4/43 • Number of events 5 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Hepatobiliary disorders ALT increased	2.9% 1/35 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Blood and lymphatic system disorders Anemia	2.9% 1/35 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Gastrointestinal disorders Diarrhea	0.00% 0/35 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Vascular disorders Thromboembolia	0.00% 0/35 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Musculoskeletal and connective tissue disorders Muscle Weakness	2.9% 1/35 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.

Other adverse events

Measure	Physician Choice Treatment n=35 participants at risk Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list). * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent glioblastoma	ChemoID-guided Treatment n=43 participants at risk Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list. * 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. ChemoID assay: The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses 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. Chemotherapy: Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent glioblastoma
General disorders Nausea	2.9% 1/35 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Blood and lymphatic system disorders Decreased hemoglobin	0.00% 0/35 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Blood and lymphatic system disorders Platelet count decreased	5.7% 2/35 • Number of events 4 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	7.0% 3/43 • Number of events 3 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Blood and lymphatic system disorders Low white blood cells count	8.6% 3/35 • Number of events 5 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	4.7% 2/43 • Number of events 3 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
General disorders Fatigue	8.6% 3/35 • Number of events 4 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Gastrointestinal disorders Constipation	2.9% 1/35 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	4.7% 2/43 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Nervous system disorders Neuropathy	5.7% 2/35 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	4.7% 2/43 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
General disorders Anorexia	2.9% 1/35 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
General disorders weight loss	2.9% 1/35 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Nervous system disorders Seizure	2.9% 1/35 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
Vascular disorders Hemorrhage	0.00% 0/35 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 1 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.
General disorders weakness	2.9% 1/35 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.	2.3% 1/43 • Number of events 2 • 5 years Clinical adverse events due to standard-of-care drugs (AEs) was monitored throughout the study. This study utilized the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for CTEP-AERS (CTEP Adverse Event Reporting System) CAERs reporting of adverse events (AEs), located on the CTEP web site, http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. All appropriate treatment areas should have access to a copy of the CTCAE version 5.0.

Additional Information

Pier Paolo Claudio, MD, Chief Scientific Officer

Cordgenics

Phone: 6064657226

Email: claudio@cordgenics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place