Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the safety of an innovative integrated treatment regimen for recurrent glioblastoma , including patients with recurrent glioblastoma multiforme.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Hospital of Hebei Medical University

Criteria

Inclusion Criteria:

• The pathological result of glioblastoma WHO grade 4;

• Received standard TMZ chemotherapy and radiotherapy;

• It is not suitable to undergo surgical resection of the lesion again or other drug treatment, or the patient refuses other treatment;

• Men and women aged 18-75;

• Disease progression was confirmed by CT or MRI examination within 4 weeks before enrollment;

• KPS score ≥70;

• Expected survival time ≥ 3 months, and can meet the follow-up requirements;

• Within 7 days before the start of treatment, the results of routine blood tests, liver and renal function tests, and hemagglutination laboratory tests meet the following criteria:

Leukocyte (WBC) ≥ 3.0×109/L

Platelets (PLT) ≥ 100×109/L

Neutrophil (ANC) ≥ 1.5×109/L

Hemoglobin (HGB) ≥ 90g/L

Serum albumin ≥2.8g/dL

Aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN) (< 5×ULN for liver metastases)

Alanine aminotransferase (ALT) ≤2.5×ULN (≤5×ULN for liver metastases)

Total bilirubin (TIBC) ≤1.5×ULN, patients with liver cancer or liver metastases should ≤2×ULN

Serum creatinine (CR)≤1.5×ULN or creatinine clearance ≥50ml/min

AST and ALT levels ≤ 2.5×ULN, and patients with liver metastases or liver cancer should ≤ 5×ULN

International Normalized ratio (INR) ≤ 1.5

Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN

• Pregnancy should be ruled out for fertile women, and HCG tests for early pregnancy must be negative; Both male and female participants should ensure that they use contraception during the study and continue to use contraception until the end of the follow-up period;

• Volunteer to participate in the clinical study, cooperate with the doctor to carry out the study, and sign the informed consent form.

Exclusion Criteria:

• Participating in another clinical trial;

• Recurrence within 4 weeks after surgery;

• Recurrence within 4 weeks after chemotherapy;

• Recurrence within 4 weeks after radiotherapy;

• Increased intracranial pressure: midline shift ≥5mm, clinically significant visual edema, vomiting and nausea, or poor level of consciousness;

• Have active infection that is not controlled with appropriate anti-infective therapy;

• Patients with mental illness or other conditions, such as uncontrollable heart disease or lung disease, diabetes, etc., cannot comply with the requirements of research treatment and monitoring;

• Organ transplants;

• Pregnant or lactating women; Persons with disabilities (blind, deaf, dumb, mentally disabled, physically disabled) or suffering from mental diseases as prescribed by law; Drug users or patients with a history of adverse drug abuse and alcohol dependence within 5 years;

• Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as a positive hepatitis B surface antigen [HBsAg] test, HBV-DNA ≥ 500 IU/ml and abnormal liver function; Hepatitis C, defined as hepatitis C antibody [HCV-AB] positive, HCV-RNA above the detection limit of the assay, and abnormal liver function) or co-infection with hepatitis B and C;

• Any other factors that the investigator deems inappropriate for the subject to participate in the study.