Skip to main content

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

Trial Status: Active

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).

Inclusion Criteria

  • 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

  • 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);

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Jon Glass
Phone: 215-955-9797

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

Lead Organization
Cordgenics, LLC

  • Primary ID CG01GBM
  • Secondary IDs NCI-2020-01297
  • Clinicaltrials.gov ID NCT03632135