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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 : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cordgenics, LLC

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE May 15, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • 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.
  • 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.
  • 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.
  • Objective Tumor Response [ Time Frame: 36 months ]
    Objective tumor response measured by RANO (Response Assessment in Neuro-oncology Criteria)
  • Quality of life questionnaire [ Time Frame: 36 months ]
    Health-Related Quality of Life questionnaire (HRQOL)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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 (OS6mo, OS9mo, OS12mo) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.
  • 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.
  • 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 (PFS4mo, PFS6mo, PFS9mo, PFS12mo) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.
  • Objective Tumor Response [ Time Frame: 36 months ]
    Objective tumor response measured by RANO (Response Assessment in Neuro-oncology Criteria)
  • HRQOL [ Time Frame: 36 months ]
    Health-Related Quality of Life (HRQOL)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma
Official Title  ICMJE Standard Chemotherapy Versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Glioblastoma Multiforme (GBM).
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Recurrent Glioblastoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Diagnostic Test: ChemoID assay
    • Drug: Chemotherapy
  • Experimental: ChemoID-guided treatment

    Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list.

    ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations:

    • Carboplatin;
    • Irinotecan;
    • Etoposide;
    • BCNU;
    • CCNU;
    • Temozolomide;
    • Procarbazine;
    • Vincristine;
    • Imatinib;
    • Procarbazine, CCNU, Vincristine;
    • Carboplatin, Irinotecan;
    • Carboplatin, Etoposide;
    • Temozolomide, Etoposide;
    • Temozolomide, Imatinib.

    The treating physician will receive the ChemoID assay results from the ChemoID lab.

    Interventions:
    • Diagnostic Test: ChemoID assay
    • Drug: Chemotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tulika Ranjan, MD 412-359-3748 Tulika.RANJAN@ahn.org
Contact: Sara Ohm, BS 412-359-8162 Sara.Ohm@AHN.ORG
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03632135
Other Study ID Numbers  ICMJE CG01GBM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cordgenics, LLC
Study Sponsor  ICMJE Cordgenics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tulika Ranjan, MD Allegheny Health Network
PRS Account Cordgenics, LLC
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP