Clinical trial NCT05589961: Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme
Official title: Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glioblastoma Multiforme
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study is a single-center, prospective, open-label, single-arm clinical study of an innovative integrated treatment regimen for recurrent glioblastoma multiforme.

The main outcome measurement of the study is to evaluate the safety of the integrated treatment regimen for glioblastoma multiforme. Secondary outcome measurement are OS, PFS, ORR, and quality of life. Safety is evaluated by monitoring adverse events, physical examination results, vital signs, ECG, hematology, and clinical biochemistry. Imaging was performed at the end of every 3 sessions to assess treatment outcome and disease progression. The whole treatment and efficacy will be observed for two years.

Eligibility 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.

Primary outcomes:
measure: To Evaluate the Safety of the Integrated Treatment Regimen for Glioblastoma Multiforme
timeFrame: From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 21 days)
Secondary outcomes:
measure: To Evaluate the survival of the Integrated Treatment Regimen for Glioblastoma Multiforme
timeFrame: From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 63 days)
measure: To Evaluate the efficacy of the Integrated Treatment Regimen for Glioblastoma Multiforme
timeFrame: From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 63 days)
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: the Second Hospital of HeBei Medical University
state: Hebei
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Chunyan Li, Academician
role: STUDY_CHAIR
References: