Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
1 other identifier
interventional
10
1 country
2
Brief Summary
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2020
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 9, 2020
December 1, 2019
2 years
May 11, 2020
June 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse Events (AE) / Serious Adverse Events (SAE)
AE/SAE associated with the intervention will be captured throughout the treatment portion of the study. All adverse events will be then compiled and these patients will be recorded.
2-3 years
Progression free survival (PFS) at 6 months
Assessed from this study start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Secondary Outcomes (2)
Immunological Assays
2-3 years
Overall survival (OS) time
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Study Arms (1)
Safety Evaluation Group
EXPERIMENTALBasic treatment phase: The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days). Immunotherapy phase: Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour.
Interventions
Vaccine is derived from the participants dendritic cells and tumor cells.
Given subcutaneously at dose of 6ug twice for interval of one hour.
Following concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years; Male or Female.
- Treatment-naïve patients after Resection of Glioblastoma.
- Histologically confirmed Glioblastoma.
- KPS ≥ 60
- White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
- Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
- Patients must be able to understand the investigational nature of the study and provide informed consent.
You may not qualify if:
- Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
- Those with severe autoimmune diseases or immunodeficiency diseases.
- Those who are expected to take systemic corticosteroids within three months.
- Those who needs long-term usage of immunosuppressive agents.
- Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
- Those who plan to receive any other anti-tumor treatment during the trial.
- Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
- Patients with other malignant tumors.
- Those with active infections, etc.
- Suspected or confirmed a history of alcohol and drug abuse.
- Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
- Women who are pregnant or nursing.
- Women of childbearing age who refuse to contraception.
- Active participation in another clinical treatment trials.
- According to the judgment of the investigator, other conditions that the plan cannot be followed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310051, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310051, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hong Shen, MD
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2020
First Posted
May 14, 2020
Study Start
December 1, 2020
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
June 9, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share