Description:
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).
Title
- Brief Title: Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma
- Official Title: Standard Chemotherapy Versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Glioblastoma Multiforme (GBM).
Clinical Trial IDs
- ORG STUDY ID:
CG01GBM
- NCT ID:
NCT03632135
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Chemotherapy | Cytotoxic chemotherapy drugs | ChemoID-guided treatment |
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).
Detailed Description
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 Arms
Name | Type | Description | Interventions |
---|
Physician Choice treatment | Active Comparator | Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the Physician from the provided list).
Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations:
Carboplatin;
Irinotecan;
Etoposide;
BCNU;
CCNU;
Temozolomide;
Procarbazine;
Vincristine;
Imatinib;
Procarbazine, CCNU, Vincristine;
Carboplatin, Irinotecan;
Carboplatin, Etoposide;
Temozolomide, Etoposide;
Temozolomide, Imatinib. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab. | |
ChemoID-guided treatment | Experimental | Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list.
ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations:
Carboplatin;
Irinotecan;
Etoposide;
BCNU;
CCNU;
Temozolomide;
Procarbazine;
Vincristine;
Imatinib;
Procarbazine, CCNU, Vincristine;
Carboplatin, Irinotecan;
Carboplatin, Etoposide;
Temozolomide, Etoposide;
Temozolomide, Imatinib.
The treating physician will receive the ChemoID assay results from the ChemoID lab. | |
Eligibility Criteria
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);
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Median Overall Survival (OS) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Overall survival (OS) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician. |
Secondary Outcome Measures
Measure: | Overall Survival at 6, 9, and 12 months (OS6mo, OS9mo, OS12mo) |
Time Frame: | 6, 9, and 12 months |
Safety Issue: | |
Description: | Overall survival at 6, 9, and 12 months in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician. |
Measure: | Median Progression Free Survival (PFS) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Median Progression Free Survival in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician. |
Measure: | Progression Free Survival at 4, 6, 9, and 12 months (PFS4mo, PFS6mo, PFS9mo, PFS12mo) |
Time Frame: | 4, 6, 9, and 12 months |
Safety Issue: | |
Description: | Progression Free survival at 4, 6, 9, and12 months in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician. |
Measure: | Objective Tumor Response |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Objective tumor response measured by RANO (Response Assessment in Neuro-oncology Criteria) |
Measure: | Quality of life questionnaire |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Health-Related Quality of Life questionnaire (HRQOL) |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Cordgenics, LLC |
Trial Keywords
- ChemoID
- Cancer stem cells
- Drug response assay
- Glioblastoma
- Brain Cancer
Last Updated
June 18, 2020