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

This is an interventional diagnostic trial for Recurrent Glioblastoma focused on measuring ChemoID, Cancer stem cells, Drug response assay, Glioblastoma, Brain Cancer Read More

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 III recurrent glioma, and grade IV recurrent glioblastoma (GBM), inclusive of Gliosarcoma
• 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. Prior to surgery there was imaging evidence of measurable progressive disease (PD);
• 9. Start of radiotherapy, if indicated, must occur at least 2 weeks after surgery and/or biopsy;
• 10. Estimated survival of at least 3 months;
• 11. 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;

• 12. If indicated radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy.

  13. 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; 14. The use of herbal preparation or tetrahydrocannabinol/cannabidiol is strongly discouraged, but not contraindicated;

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); 7. 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; 8. OPTUNE device is not permitted in the study; 9. Patients cannot participate to any clinical trials utilizing a liquid biomarker or imaging studies that impact the overall survival.