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

June 7, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hong Shen, MD
  • Phone Number: 8613805730380
  • Email: sh_2nd@126.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310051
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
        • Contact:
      • Hangzhou, Zhejiang, China, 310051
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety Evaluation Group

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.
Biological: Dendritic Cell/Tumor Fusion Vaccine
Vaccine is derived from the participants dendritic cells and tumor cells.
Other Names:
  • DC/tumor cell fusion vaccine
Drug: Interleukin-12
Given subcutaneously at dose of 6ug twice for interval of one hour.
Other Names:
  • IL-12
Drug: Temozolomide
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.
Other Names:
  • TMZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AE) / Serious Adverse Events (SAE)
Time Frame: 2-3 years
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological Assays
Time Frame: 2-3 years
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.
2-3 years
Overall survival (OS) time
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
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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Hangzhou Medical Biotechnology Co., Ltd
CyTIX.Inc

Investigators

  • Study Chair: Hong Shen, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDKZJU-DCf12-2019408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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