Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma (CSCRGBM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03632135 |
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Recruitment Status :
Recruiting
First Posted : August 15, 2018
Last Update Posted : June 18, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Glioblastoma | Diagnostic Test: ChemoID assay Drug: Chemotherapy | Phase 3 |
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 : | Interventional (Clinical Trial) |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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:
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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 |
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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:
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 |
- 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.
- 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)
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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);
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
| Contact: Tulika Ranjan, MD | 412-359-3748 | Tulika.RANJAN@ahn.org | |
| Contact: Sara Ohm, BS | 412-359-8162 | Sara.Ohm@AHN.ORG |
| United States, California | |
| Kaiser Permanente | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Richard Green, MD 323-783-4011 Sandra.T.Baker@kp.org | |
| Contact: Sandra Baker-Bolden (323) 783-5532 Sandra.T.Baker@kp.org | |
| Principal Investigator: Richard Green, MD | |
| 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 | |
| Principal Investigator: Aaron Mammoser, MD | |
| 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 Cancer Institute | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Soma Sengupta, MD, PhD 513-558-5457 sengupsm@ucmail.edu | |
| Contact: Cathy Bailey 513-558-8195 baileyca@ucmail.uc.edu | |
| Principal Investigator: Soma Sengupta, MD, PhD | |
| 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: Scott Stanley, MS 717-531-0003 ext 285799 sstanley2@pennstatehealth.psu.edu | |
| Principal Investigator: Dawit Aregawi, MD | |
| Thomas Jefferson University Hospitals | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jon Glass, MD 215-955-9797 jon.glass@jefferson.edu | |
| Contact: Elizabeth Schultz, CRC 215-955-5891 Elizabeth.Schultz@jefferson.edu | |
| Principal Investigator: Jon Glass, MD | |
| Allegheny Health Network | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Tulika Ranjan, MD 412-770-3039 Tulika.RANJAN@ahn.org | |
| Contact: Sara Ohm, BS 412-359-8162 Sara.Ohm@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 | |
| Principal Investigator: | Tulika Ranjan, MD | Allegheny Health Network |
| Responsible Party: | Cordgenics, LLC |
| ClinicalTrials.gov Identifier: | NCT03632135 |
| Other Study ID Numbers: |
CG01GBM |
| First Posted: | August 15, 2018 Key Record Dates |
| Last Update Posted: | June 18, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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ChemoID Cancer stem cells Drug response assay Glioblastoma Brain Cancer |
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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 |