Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Irinotecan

Temozolomide

Vincristine

Lomustine

Etoposide phosphate

Imatinib Mesylate

Procarbazine

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.

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.

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.

ChemoID assay

Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent high-grade glioma

Chemotherapy

Tulika Ranjan, MD

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).

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.

parallel group randomized controlled clinical trial

Study investigators will be kept blind to the schedule. All participants will be screened by the ChemoID drug response assay; however, the treating physician will receive the ChemoID results only for those participants who are randomized to ChemoID-guided treatment arm.

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

Standard Chemotherapy Versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Glioblastoma Multiforme (GBM).

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

Overall survival at 6, 9, and 12 months in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.

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

Progression Free survival at 4, 6, 9, and12 months in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.

Objective tumor response measured by RANO (Response Assessment in Neuro-oncology Criteria)

Health-Related Quality of Life questionnaire (HRQOL)

Cordgenics, LLC

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.

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

Physician Choice 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 glioblastoma

ChemoID-guided Treatment

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

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

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Pier Paolo Claudio, MD, Chief Scientific Officer

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

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

Spots Global Cancer Trial Database for Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial