BIP_CG01-GBM

Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM)

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 Inclusion Criteria:
-Histopathologically confirmed WHO grad IV recurrent glioblastoma (GBM).
-Recurrent surgically resectable tumor and/or biopsy
-Start of radiotherapy, if indicated, must occur at least 2 weeks after srugery and/or biopsy
-Estimated survival of at least 3 months
-Hgb > 9 gm; absolute neutrophil count (ANC) > 1500/μl; platements > 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
Key Exclusion Criteria:
-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

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase III
NCT03632135
Neurosciences
Neuro-oncology
Ricky Chen, M.D.
Cordgenics, LLC
Kyla Lindberg
  • Providence St. Vincent Medical Center