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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04277221
Other study ID # ADCTA-SSI-G1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 19, 2019
Est. completion date December 31, 2022

Study information

Verified date March 2020
Source Safe Save Medical Cell Sciences & Technology Co.,Ltd.
Contact Wen-Kuang Yang, PhD
Phone +886-3-5506696
Email wkyang@safesavecell.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 therapy alone in patients with recurrent GBM.


Recruitment information / eligibility

Status Recruiting
Enrollment 118
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. 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

2. 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:

1. White blood cell (WBC) count = 2,000/mm^3;

2. Absolute neutrophil count (ANC) = 1,000/mm^3;

3. Platelets = 100,000/mm^3;

4. Hemoglobin (Hgb) = 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb = 8.0 g/dL is acceptable.);

5. Blood Urea Nitrogen (BUN) < 30 mg/dL;

6. Creatinine < 2 mg/dL;

7. Renal function: calculated creatinine clearance = 30 mL/min;

8. Hepatic function: Total bilirubin = 3 times upper limit of normal (ULN), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 2 times ULN;

9. 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 Criteria:

1. 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

2. 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:

1. Subject with clinically defined Acquired Immune-Deficiency Syndrome (AIDS)-defining illness;

2. Subjects with acute hepatitis C or B infection;

3. Severe hepatic impairment (Child-Pugh category C or higher);

4. Electrocardiogram (ECG) with evidence of acute cardiac ischemia prior to randomization;

5. Transmural myocardial infarction or ischemia prior to enrollment;

6. 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Autologous Dendritic Cell/Tumor Antigen, ADCTA
ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital, Chiayi branch Chiayi City
Taiwan Chang Gung Memorial Hospital, Kaohsiung branch Kaohsiung City
Taiwan Chang Gung Memorial Hospital, Keelung branch Keelung
Taiwan Taichung Veterans General Hospital Taichung City
Taiwan Chi Mei Medical Center Tainan City
Taiwan National Cheng Kung University Hospital Tainan City
Taiwan Chang Gung Memorial Hospital, Linkou branch Taoyuan City

Sponsors (1)

Lead Sponsor Collaborator
Safe Save Medical Cell Sciences & Technology Co.,Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chang CN, Huang YC, Yang DM, Kikuta K, Wei KJ, Kubota T, Yang WK. A phase I/II clinical trial investigating the adverse and therapeutic effects of a postoperative autologous dendritic cell tumor vaccine in patients with malignant glioma. J Clin Neurosci. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) The duration will be calculated from the date of randomization until the date of death from any cause, assessed up to 60 months.
Secondary Progression-free Survival (PFS) The duration will be calculated from the date of randomization until the date of first documented progression according to the modified RANO or date of death from any cause, whichever came first,assessed up to 60 months.
Secondary Progression-free Survival at 6 months (PFS6) The duration will be calculated from the date of randomization to the date of the sixth month.
Secondary 1 and 2-year Survival Rate The duration will be calculated from the date of randomization to the date of the first year and the second year.
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