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

Second Affiliated Hospital, Zhejiang University, School of Medicine10 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms

Interventions

Dendritic Cell/Tumor Fusion VaccineBIOLOGICAL

Vaccine is derived from the participants dendritic cells and tumor cells.

Interleukin-12DRUG

Given subcutaneously at dose of 6ug twice for interval of one hour.

TemozolomideDRUG

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

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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).

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 Outcomes

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.