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

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ClinicalTrials.gov Identifier: NCT03632135
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Cordgenics, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Diagnostic Test: ChemoID assay Drug: Chemotherapy Phase 3

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.


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Study Type : Interventional
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel group randomized controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Standard Chemotherapy Versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Glioblastoma Multiforme (GBM).
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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.


Drug: Chemotherapy
Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent ovarian cancer
Other Name: Cytotoxic chemotherapy drugs

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

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.


Drug: Chemotherapy
Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent ovarian cancer
Other Name: Cytotoxic chemotherapy drugs




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


Secondary Outcome Measures :
  1. Overall Survival at 6, 9, and 12 months (OS6mo, OS9mo, OS12mo) [ Time Frame: 6, 9, and 12 months ]
    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.

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

  3. Progression Free Survival at 4, 6, 9, and 12 months (PFS4mo, PFS6mo, PFS9mo, PFS12mo) [ Time Frame: 4, 6, 9, and 12 months ]
    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.

  4. Objective Tumor Response [ Time Frame: 36 months ]
    Objective tumor response measured by RANO (Response Assessment in Neuro-oncology Criteria)

  5. Quality of life questionnaire [ Time Frame: 36 months ]
    Health-Related Quality of Life questionnaire (HRQOL)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. 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;
  • 2. Informed consent obtained and signed;
  • 3. Willing and able to commit to study procedures including long-term follow-up visit(s);
  • 4. Histopathologically confirmed WHO grade IV recurrent glioblastoma (GBM).
  • 5. In all cases, the diagnosis must be confirmed by a pathologist.
  • 6. Recurrent surgically resectable tumor and/or biopsy;
  • 7. 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;
  • 8. Start of radiotherapy, if indicated, must occur at least 2 weeks after surgery and/or biopsy;
  • 9. Estimated survival of at least 3 months;
  • 10. 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;
  • 11. If indicated radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy.

Exclusion Criteria:

  • 1. Subjects with newly diagnosed GBM
  • 2. 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;
  • 3. Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3
  • 4. Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
  • 5. Patient unable to follow procedures, visits, examinations described in the study;
  • 6. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632135


Contacts
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Contact: Tulika Ranjan, MD 412-359-3748 Tulika.RANJAN@ahn.org
Contact: Joshua Woolford, RN 412-359-3595 Joshua.Woolford@AHN.ORG

Locations
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United States, Louisiana
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Aaron Mammoser, MD    504-568-2698    amammo@lsuhsc.edu   
Contact: Melissa Ensminger, RN    504-568-2507    mensmi@lsuhsc.edu   
United States, Maine
Maine Medical Center Research Institute Recruiting
Scarborough, Maine, United States, 04074
Contact: Christine Lu-Emerson, MD       CLuEmerson@mmc.org   
Contact: Logan Ahmann, CCRP    207-396-8377    LAhmann@mmc.org   
Principal Investigator: Christine Lu-Emerson, MD         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Mark D. Anderson, MD    601-984-5517    manderson4@umc.edu   
Contact: Jennifer Barnes, RHIA, CCRP    601-815-4550    jbarnes@umc.edu   
Principal Investigator: Mark Anderson, MD         
United States, New Jersey
Garden State Neurology and Neuro-oncology Recruiting
West Long Branch, New Jersey, United States, 07764
Contact: Samul N Raval, MD    732-229-6200    Drraval@gmail.com   
Contact: Kaitlyn Reiff, APN    732-229-6200    kaitlynreiff@gmail.com   
Principal Investigator: Samul Raval, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Rekha Chaudhary, MD    513-475-8500    tripatrr@uc.edu   
Contact: Maxwell Mays, BS    513-584-8195    maxwell.mays@uc.edu   
Principal Investigator: Rekha Chaudhary, MD         
Toledo University Recruiting
Toledo, Ohio, United States, 43614
Contact: Jason Schroeder, MD    419-383-4000    Jason.Schroeder5@UToledo.edu   
Contact: Stephanie Smiddy, RN,CCRC    419-383-6962    stephanie.smiddy@UToledo.edu   
Principal Investigator: Jason Schroeder, MD         
United States, Oregon
Providence Cancer Center Oncology Recruiting
Portland, Oregon, United States, 97225
Contact: Kyla Lindberg, RN, BSN    503-216-1191    Kyla.Lindberg@Providence.org   
Contact: Rick Chen, MD       Ricky.Chen2@providence.org   
Principal Investigator: Ricky Chen, MD         
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Gavinski Megan    484-503-4157    Megan.Gavinski@sluhn.org   
Contact: Hugh Moulding, MD       Hugh.moulding@sluhn.org   
Principal Investigator: Hugh Moulding, MD         
The Penn State Univeristy College of Medicine Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Dawit Aregawi, MD    717-531-3828    daregawi@PennStateHealth.psu.edu   
Contact: Brennen A Harding, MS    717-531-0003 ext 285799    bharding@pennstatehealth.psu.edu   
Principal Investigator: Dawit Aregawi, MD         
Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Tulika Ranjan, MD    412-770-3039    Tulika.RANJAN@ahn.org   
Contact: Joshua Woolford, RN    412-359-3595    joshua.woolford@ahn.org   
Principal Investigator: Tulika Ranjan, MD         
United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston, West Virginia, United States, 25326
Contact: Steven Jubelirer, MD    304-388-8380    steven.jubelirer@camc.org   
Contact: Augusta Kosowicz, PA-C, CCRC    304-388-9940    augusta.kosowicz@camc.org   
Principal Investigator: Steven Jubelirer, MD         
Sponsors and Collaborators
Cordgenics, LLC
Investigators
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Principal Investigator: Tulika Ranjan, MD Allegheny Health Network

Publications of Results:
Tulika Ranjan, Candace M. Howard, Jagan Valluri, Alexander Yu, Khaled Aziz, David Jho, Terrence Julien, Jody Leonardo, Anthony Alberico, Antonio Cortese, Krista Denning, and Pier Paolo Claudio. Prospective Analysis of Cancer Stem Cell Drug Response Assay for Glioblastoma Patients. J Clin Oncol 36, 2018 (suppl; abstr 2057) - ASCO Annual Meeting, Chicago, June 1-5, 2018.
Candace M Howard, Anthony Alberico, Jagan Valluri, Michael Griswold, and Pier Paolo Claudio. Analysis of chemo-predictive assay for targeting cancer stem cells in 41 glioblastoma patients. Journal of Clinical Oncology 2017 35:15_suppl, e13544-e13544

Other Publications:
Pier Paolo Claudio, Sarah E Mathis, Rounak Nande, Anthony Alberico, Walter Neto, Logan Lawrence, James Denvir, Gerrit A. Kimmey, Aneel A. Chowdhary, Maria R. B. Tria Tirona, Mark Jeffrey Mogul, Terrence D Julien, Rida S Mazagri, Gerald Oakley, Krista L Denning, Thomas Dougherty, Linda Brown, and Jagan Valluri. Novel chemosensitivity assay for targeting cancer stem-like cells in brain tumors. Journal of Clinical Oncology 2014 32:15_suppl, e13012-e13012

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Responsible Party: Cordgenics, LLC
ClinicalTrials.gov Identifier: NCT03632135     History of Changes
Other Study ID Numbers: CG01GBM
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cordgenics, LLC:
ChemoID
Cancer stem cells
Drug response assay
Glioblastoma
Brain Cancer
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue