Neoantigen Vaccine Therapy Against H3.3-K27M Diffuse Intrinsic Pontine Glioma (ENACTING)
Diffuse Intrinsic Pontine Glioma
About this trial
This is an interventional treatment trial for Diffuse Intrinsic Pontine Glioma
Eligibility Criteria
Inclusion Criteria:
A. First entry criteria
- Age ≥ 5 years old;
- Newly-diagnosed patients with DIPG appearance on MRI image;
- HLA-A2 subtype;
- The expected survival time exceeds 24 weeks;
- The KPS score is greater than 50; B. Second entry criteria
1. The KPS score is greater than 50; 2. DIPG is diagnosed histologically on tumor tissue obtained by biopsy or surgical resection; 3. H3.3K27M mutation is detected on tumor tissue obtained by biopsy or surgical resection ; 4. Adequate organ functions that meet the following criteria: The absolute number of neutrophils: ≥1500/mm3 Platelet count: ≥75000/uL Hemoglobin: ≥80 g/L Creatinine≤1.5×ULN Bilirubin≤1.5×ULN ALT≤3×ULN AST≤3×ULN 5. Ability to comprehend and sign an informed consent form.
Exclusion Criteria:
- With past medical history of malignant tumors (except being asymptomatic for more than 3 years);
- History of allergy to chemotherapeutics or radiosensitizers for the treatment of cancer in central nervous system and head/neck;
- History of allergy to the vaccine and its ingredients;
- Comorbidity with HIV infection and/or acute phase of hepatitis B/C;
- Any progressive diseases that hinder participation in the trial;
- With unstable cardiovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia et.al.;
- History of uncontrolled mental illnesses;
- Inability to comprehend or sign informed consent form or abide by the research procedures;
- Other conditions believed to hinder participation in this trial at investigator' discretion.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Open surgical biopsy
Stereotactic biopsy
A total of 15 subjects with open surgical biopsy indications will receive microsurgical resection, followed by conformal radiotherapy and administration of the researched vaccine.
A total of 15 subjects without open surgical biopsy indications will receive stereotactic biopsy, followed by conformal radiotherapy and administration of the researched vaccine.