Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma
- 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.
- 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);
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.
Trial Phase Phase III
Trial Type Diagnostic
- Primary ID CG01GBM
- Secondary IDs NCI-2020-01297
- Clinicaltrials.gov ID NCT03632135