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



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:May 15, 2018
End Date:January 31, 2022
Contact:Tulika Ranjan, MD
Email:Tulika.RANJAN@ahn.org
Phone:412-359-3748

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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).

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);
We found this trial at
7
sites
PIttsburgh, Pennsylvania 15212
Phone: 412-770-3039
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Phone: 601-984-5517
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Charleston, West Virginia 25304
Phone: 304-388-8380
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-558-3559
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Hershey, Pennsylvania 17033
Phone: 717-531-3828
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Toledo, Ohio 43614
Phone: 419-383-4000
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West Long Branch, New Jersey 07764
Phone: 732-229-6200
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West Long Branch, NJ
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