Clinical Trials /

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

NCT03632135

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).

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

  • Recurrent Glioblastoma

Interventions

DrugSynonymsArms
ChemotherapyCytotoxic chemotherapy drugsChemoID-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

NameTypeDescriptionInterventions
Physician Choice treatmentActive ComparatorParticipants 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.
  • Chemotherapy
ChemoID-guided treatmentExperimentalParticipants 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.
  • Chemotherapy

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 16, 2020