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

Completed · Phase 3

Conditions studied: Recurrent Glioblastoma

In brief

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).

Key facts

Study ID

NCT03632135

Run by

Cordgenics, LLC

People needed

78

Starts

2018-05-20

Expected to finish

2023-12-31

Last updated by the study team

2025-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• 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;
• If indicated radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy.
• Bevacizumab (Avastin) is allowed. If indicated it should be initiated at least 4 weeks post craniotomy or biopsy if the wound has healed well without any drainage or cellulitis;
• The use of herbal preparation or tetrahydrocannabinol/cannabidiol is strongly discouraged, but not contraindicated;

You may not qualify if…

• 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.

Where it is running

• Kaiser Permanente — Los Angeles, California, United States
• Keck School of Medicine of the University of Southern California — Los Angeles, California, United States
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• Maine Medical Center Research Institute — Scarborough, Maine, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• Toledo University — Toledo, Ohio, United States
• Providence Cancer Center Oncology — Portland, Oregon, United States
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
• The Penn State Univeristy College of Medicine — Hershey, Pennsylvania, United States
• Thomas Jefferson University Hospitals — Philadelphia, Pennsylvania, United States
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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