search
Back to results

Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.

Primary Purpose

Glioblastoma, Glioma, Neoplasms, Neuroepithelial

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dendritic Cell/Tumor Fusion Vaccine
Interleukin-12
Temozolomide
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years; Male or Female.
  2. Treatment-naïve patients after Resection of Glioblastoma.
  3. Histologically confirmed Glioblastoma.
  4. KPS ≥ 60
  5. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
  6. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
  7. Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

  1. Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
  2. Those with severe autoimmune diseases or immunodeficiency diseases.
  3. Those who are expected to take systemic corticosteroids within three months.
  4. Those who needs long-term usage of immunosuppressive agents.
  5. Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
  6. Those who plan to receive any other anti-tumor treatment during the trial.
  7. 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.
  8. Patients with other malignant tumors.
  9. Those with active infections, etc.
  10. Suspected or confirmed a history of alcohol and drug abuse.
  11. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
  12. Women who are pregnant or nursing.
  13. Women of childbearing age who refuse to contraception.
  14. Active participation in another clinical treatment trials.
  15. According to the judgment of the investigator, other conditions that the plan cannot be followed.

Sites / Locations

  • The Second Affiliated hospital of Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Safety Evaluation Group

Arm Description

Basic 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Immunological Assays
Assays including Flow Cytometry and Elispot will be employed to determine if cellular and humoral immunity were induced by serial vaccination with DC/Tumor Fusion Cells and IL-12.
Overall survival (OS) time
Assessed from this study start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).

Full Information

First Posted
May 11, 2020
Last Updated
June 7, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Hangzhou Medical Biotechnology Co., Ltd, CyTIX.Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT04388033
Brief Title
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
Official Title
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Hangzhou Medical Biotechnology Co., Ltd, CyTIX.Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors, Neoplasms, Neoplasms, Nerve Tissue, Vaccines, Immunologic Factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety Evaluation Group
Arm Type
Experimental
Arm Description
Basic 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.
Intervention Type
Biological
Intervention Name(s)
Dendritic Cell/Tumor Fusion Vaccine
Other Intervention Name(s)
DC/tumor cell fusion vaccine
Intervention Description
Vaccine is derived from the participants dendritic cells and tumor cells.
Intervention Type
Drug
Intervention Name(s)
Interleukin-12
Other Intervention Name(s)
IL-12
Intervention Description
Given subcutaneously at dose of 6ug twice for interval of one hour.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
TMZ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events (AE) / Serious Adverse Events (SAE)
Description
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.
Time Frame
2-3 years
Title
Progression free survival (PFS) at 6 months
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Immunological Assays
Description
Assays including Flow Cytometry and Elispot will be employed to determine if cellular and humoral immunity were induced by serial vaccination with DC/Tumor Fusion Cells and IL-12.
Time Frame
2-3 years
Title
Overall survival (OS) time
Description
Assessed from this study start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Shen, MD
Phone
8613805730380
Email
sh_2nd@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Shen, MD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Shen, MD
Phone
8613805730380
Email
sh_2nd@126.com
First Name & Middle Initial & Last Name & Degree
Chongran Sun, MD
Phone
8615925612402
Email
2307101@zju.edu.cn
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310051
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caixing Sun, MD
Phone
8613777820122
Email
2226124552@qq.com
First Name & Middle Initial & Last Name & Degree
Liang Xia, MD
Phone
8615168272549
Email
xialiang@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.

We'll reach out to this number within 24 hrs