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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cordgenics, LLC

Criteria

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.