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

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.

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 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.

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);