Standard Chemotherapy Versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Glioblastoma Multiforme (GBM).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 13
- 主要终点
- Median Overall Survival (OS)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study investigators will be kept blind to the schedule. All participants will be screened by the ChemoID drug response assay; however, the treating physician will receive the ChemoID results only for those participants who are randomized to ChemoID-guided treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Informed consent obtained and signed;
- •Willing and able to commit to study procedures including long-term follow-up visit(s);
- •Histopathologically confirmed 2016-WHO grade III recurrent glioma, and grade IV recurrent glioblastoma (GBM), inclusive of Gliosarcoma
- •In all cases, the diagnosis must be confirmed by a pathologist.
- •Recurrent surgically resectable tumor and/or biopsy;
- •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;
- •Prior to surgery there was imaging evidence of measurable progressive disease (PD);
- •Start of radiotherapy, if indicated, must occur at least 2 weeks after surgery and/or biopsy;
- •Estimated survival of at least 3 months;
- •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;
- •If indicated radiation therapy and chemotherapy must start within 8 weeks of tumor resection or biopsy.
- •Bevacizumab (Avastin) is allowed. If indicated it should be initiated at least 4 weeks post craniotomy or biopsy if the wound has healed well without any drainage or cellulitis;
- •The use of herbal preparation or tetrahydrocannabinol/cannabidiol is strongly discouraged, but not contraindicated;
排除标准
- •Subjects with newly diagnosed GBM
- •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;
- •Abnormal hematological results at inclusion with: Neutrophils < 1,500/mm3; Blood-platelets < 100,000/mm3
- •Severe or chronic renal insufficiency (creatinine clearance ≤ 30 ml/min);
- •Patient unable to follow procedures, visits, examinations described in the study;
- •Any usual formal indication against imaging examinations (important claustrophobia, pacemaker);
- •History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer, any time prior to screening, are eligible;
- •OPTUNE device is not permitted in the study;
- •Patients cannot participate to any clinical trials utilizing a liquid biomarker or imaging studies that impact the overall survival.
研究组 & 干预措施
Physician Choice treatment
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.
干预措施: ChemoID assay (Diagnostic Test)
Physician Choice treatment
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.
干预措施: Chemotherapy (Drug)
ChemoID-guided treatment
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.
干预措施: ChemoID assay (Diagnostic Test)
ChemoID-guided treatment
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.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Median Overall Survival (OS)
时间窗: 36 months
Overall survival (OS) in recurrent GBM patients who have had a ChemoID assay-guided treatment compared to standard therapy chosen by the physician.
次要结局
- Median Progression Free Survival (PFS)(36 months)