Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Doxorubicin

Liposomal doxorubicin

Topotecan

Cisplatin

Participants will be treated with control chemotherapy treatment (Bevacizumab plus 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:

* Liposomal Doxorubicin;
* Docetaxel;
* Paclitaxel;
* Carboplatin;
* Cisplatin;
* Gemcitabine;
* Topotecan;
* Carboplatin, Gemcitabine;
* Cisplatin, Gemcitabine;
* Carboplatin, Liposomal Doxorubicin;
* Carboplatin, Paclitaxel;
* Carboplatin, Docetaxel.

The treating physician will NOT receive the ChemoID assay results from the ChemoID lab.

Participants will be treated with Bevacizumab plus 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:

* Liposomal Doxorubicin;
* Docetaxel;
* Paclitaxel;
* Carboplatin;
* Cisplatin;
* Gemcitabine;
* Topotecan;
* Carboplatin, Gemcitabine;
* Cisplatin, Gemcitabine;
* Carboplatin, Liposomal Doxorubicin;
* Carboplatin, Paclitaxel;
* Carboplatin, Docetaxel.

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 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 ovarian cancer.

Chemotherapy list:

* Liposomal Doxorubicin;
* Docetaxel;
* Paclitaxel;
* Carboplatin;
* Cisplatin;
* Gemcitabine;
* Topotecan;
* Carboplatin, Gemcitabine;
* Cisplatin, Gemcitabine;
* Carboplatin, Liposomal Doxorubicin;
* Carboplatin, Paclitaxel;
* Carboplatin, Docetaxel.

Chemotherapy

Kelly J Wilkinson, MD

The purpose of this randomized clinical study is to confirm the utility of chemosensitivity (ChemoID) tumor testing on cancer stem cells as a predictor of clinical response in recurrent epithelial ovarian cancer (EOC), fallopian tube, or primary peritoneal cancer, regardless of platinum sensitivity.

Population studied will be female participants experiencing a 1st, 2nd, or 3rd recurrence of any stage epithelial ovarian cancer.

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

Upon obtaining informed consent, all eligible participants affected by 1st, 2nd, or 3rd relapse of EOC regardless of platinum sensitivity (both platinum sensitive and resistant) will have a tumor biopsy or a cancer-positive fluid collection sample 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 (Bevacizumab plus chemotherapy chosen by the Physician from the provided list), or to a study arm of Bevacizumab plus FDA-approved drugs selected by the ChemoID drug response assay.

A stratified randomization approach for treatment arm assignment will be used with strata based on relapse number, platinum sensitivity, and study site to ensure balance within these cells.

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 receive ChemoID-guided treatment arm.

Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer

Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Platinum-Resistant or -Sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Progression free survival (PFS) in patients with recurrent epithelial ovarian cancer (EOC) who receive standard of care treatment (Bevacizumab plus chemotherapy chosen by the Physician from the provided list) versus Bevacizumab plus ChemoID drug response assay-directed chemotherapy.

Overall survival (OS) in patients with recurrent EOC who receive standard of care treatment (Bevacizumab plus chemotherapy chosen by the Physician from the provided list) versus Bevacizumab plus ChemoID drug response assay-directed chemotherapy.

ORR: partial or complete response by RECIST v1.1 (Response Evaluation Criteria In Solid Tumors)

Cordgenics, LLC

Nervous System Diseases

Glioblastoma

Brain Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Etoposide

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.

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

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.

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)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer	NCT03632798	Recurrent Ovari...	ChemoID assay Chemotherapy	18 Years -	Cordgenics, LLC
Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma	NCT03632135	Recurrent Gliob...	ChemoID assay Chemotherapy	18 Years -	Cordgenics, LLC
Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma	NCT03632135	Recurrent Gliob...	ChemoID assay Chemotherapy	18 Years -	Cordgenics, LLC

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