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Active Clinical Trials

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

Active
Allegheny General Hospital
Allegheny General Hospital

Category:
Cancer - Brain
Sponsor: 
ChemoID
Contact: 

For more information, please contact Josh Woolford at 412-359-3826 or Josh.Woolford@ahn.org.

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

Purpose: 

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).  At recurrence, a minority of patients is eligible for second surgery or re-irradiation, based on appropriate patient selection.

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 glioblastoma (GBM).  
  5. In all cases, the diagnosis must be confirmed by a pathologist.
  6. Recurrent surgically resectable tumor;
  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. Surgery and/or biopsy must have occurred 45 days before the start of radiotherapy if indicated;
  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. Patient unable to follow procedures, visits, examinations described in the study;
  2. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);
  3. Subjects with newly diagnosed GBM
  4. Patients with contraindications for MRI scanning;
  5. 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;
  6. Abnormal hematological results at inclusion with:

Neutrophils < 1,500/mm3

Blood-platelets < 100,000/mm3

  1. Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
  2. Patient unable to follow procedures, visits, examinations described in the study;
  3. Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);