Status:
UNKNOWN
ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)
Lead Sponsor:
Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To confirm the result of previous Phase I/II and phase II clinical trials, this trial is to test the efficacy and safety of ADCTA immunotherapy plus the standard therapy in comparison with standard th...
Eligibility Criteria
Inclusion
- Specimen collection screening
- Karnofsky performance status (KPS) ≥ 60 at assessment prior to surgery
- ≥ 18 and ≤ 70 years of age
- Subject has been diagnosed with GBM and has undergone resection surgery followed by standard brain RT + concurrent temozolomide and adjuvant temozolomide, and progression occurred. The foregoing progression is defined as when patients with primary GBM experience an image or clinical deterioration after receiving standard of care.
- Contrast-enhanced MRI suspects recurrent GBM
- Supratentorial tumor
- Must voluntarily sign and date informed consent form for specimen acquisition and future use, for study screening, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
- Study screening
- Karnofsky performance status (KPS) ≥ 60 at randomization
- Submission of fresh tumor
- Post-operation contrast-enhanced MRI scan must be done after surgical resection, with the intent for cyto-reduction ≥ 80% of the contrast-enhancing tumor mass
- Histologically confirmed WHO grade IV glioma by pathology tissue screening
- Subjects receiving bevacizumab as standard of care for given indication
- Subject has adequate bone marrow, renal, and hepatic function prior to randomization as follow:
- White blood cell (WBC) count ≥ 2,000/mm\^3;
- Absolute neutrophil count (ANC) ≥ 1,000/mm\^3;
- Platelets ≥ 100,000/mm\^3;
- Hemoglobin (Hgb) ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.);
- Blood Urea Nitrogen (BUN) \< 30 mg/dL;
- Creatinine \< 2 mg/dL;
- Renal function: calculated creatinine clearance ≥ 30 mL/min;
- Hepatic function: Total bilirubin ≤ 3 times upper limit of normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN;
- Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 times ULN unless therapeutically warranted.
- Subjects with recurrent GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process
- Must voluntarily sign and date informed consent form, for study participation, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any study-specific procedures
Exclusion
- Specimen collection screening
- Multifocal GBM
- Prior invasive malignancy (except for non-melanomatous skin cancer; carcinoma in situ of breast, oral cavity or cervix) unless disease free for ≥ 2 years
- Subject has used bevacizumab or immune checkpoint blockade to treat GBM
- Lactating or pregnant female
- Positive viral serology for HIV or syphilis at time of screening
- Study screening
- Subjects having a biopsy only at surgery or tumor cell insufficiency at preparation
- Inability to undergo contrast-enhanced MRI scans
- Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia)
- Inability to stop or decrease the use of corticosteroid doses to 4 mg/day prior to randomization
- Tumor progression documented according to modified RANO criteria prior to randomization (approximately 5 weeks after surgery)
- Severe, active comorbidity, defined as follow:
- Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness;
- Subjects with acute hepatitis C or B infection;
- Severe hepatic impairment (Child-Pugh category C or higher);
- Electrocardiogram (ECG) with evidence of acute cardiac ischemia prior to randomization;
- Transmural myocardial infarction or ischemia prior to enrollment;
- Any other major medical illnesses or psychiatric impairments that in the Investigator's opinion will prevent administration or completion of protocol therapy
- Subject used Gliadel wafer implant in surgery during screening process
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04277221
Start Date
September 19 2019
End Date
December 31 2022
Last Update
March 17 2020
Active Locations (7)
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1
Chang Gung Memorial Hospital, Chiayi branch
Chiayi City, Taiwan, 613
2
Chang Gung Memorial Hospital, Kaohsiung branch
Kaohsiung City, Taiwan, 833
3
Chang Gung Memorial Hospital, Keelung branch
Keelung, Taiwan, 204
4
Taichung Veterans General Hospital
Taichung, Taiwan, 407