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

Cordgenics, LLC13 sites in 1 country78 target enrollmentMay 20, 2018

ConditionsRecurrent Glioblastoma

InterventionsChemoID assay Chemotherapy

DrugsChemotherapy

Overview

Phase: Phase 3
Intervention: ChemoID assay
Conditions: Recurrent Glioblastoma
Sponsor: Cordgenics, LLC
Enrollment: 78
Locations: 13
Primary Endpoint: Median Overall Survival (OS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 20, 2018

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cordgenics, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•Informed consent obtained and signed;
•Willing and able to commit to study procedures including long-term follow-up visit(s);
•Histopathologically confirmed 2016-WHO grade III recurrent glioma, and grade IV recurrent glioblastoma (GBM), inclusive of Gliosarcoma
•In all cases, the diagnosis must be confirmed by a pathologist.
•Recurrent surgically resectable tumor and/or biopsy;
•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;
•Prior to surgery there was imaging evidence of measurable progressive disease (PD);
•Start of radiotherapy, if indicated, must occur at least 2 weeks after surgery and/or biopsy;
•Estimated survival of at least 3 months;

Exclusion Criteria

•Subjects with newly diagnosed GBM
•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;
•Abnormal hematological results at inclusion with: Neutrophils \< 1,500/mm3; Blood-platelets \< 100,000/mm3
•Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
•Patient unable to follow procedures, visits, examinations described in the study;
•Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);
•History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer, any time prior to screening, are eligible;
•OPTUNE device is not permitted in the study;
•Patients cannot participate to any clinical trials utilizing a liquid biomarker or imaging studies that impact the overall survival.

Arms & Interventions

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.

Intervention: ChemoID assay

Physician Choice treatment

Intervention: Chemotherapy

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.

Intervention: ChemoID assay