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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    10
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 24 January 2021
ejection fraction
tumor cells
cancer chemotherapy
glioblastoma multiforme
temozolomide
mg++

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-nave patients after resection of glioblastoma.

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.

Details
Condition Neuroectodermal Tumor, Neurectoderma, biological response modifier, Cancer, Cancer/Tumors, Neoplasms, Cancer (Pediatric), Ewing's Family Tumors, Cancer, Glioma, Gliomas, Glioblastoma Multiforme, Glioblastoma Multiforme, Vaccine Therapy, Gliomatosis cerebri, Vaccines, Vaccines, Neoplasms, Nerve Tissue, Germ cell tumor, Germ Cell Tumors, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neurectoderma, Gliomas, Neoplasms, Germ Cell Tumors, Therapeutic Vaccine, glioblastoma, glial tumor
Treatment Temozolomide, Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12
Clinical Study IdentifierNCT04388033
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years; Male or Female
Treatment-nave 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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