Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589961
• Other study ID #: HebeiSH_GBM_V1.0
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 2022
• Est. completion date: July 2024

Study information

• Verified date: October 2022
• Source: The Second Hospital of Hebei Medical University
• Contact: Chunyan Li, Academician
• Phone: 0311-87064024
• Email: hebeichunyanli[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• TMZ
After enrollment, temozolomide 50mg/m2 was given orally for QD until progression, and radiotherapy and PF 0.2g/ time for TID were started one week later until progression. Pembrolizumab 200mg once every 3 weeks until progression; The radiotherapy regimen depends on the patient's recurrence and initial treatment.

Locations

Country	Name	City	State
China	the Second Hospital of HeBei Medical University	Shijia Zhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Evaluate the Safety of the Integrated Treatment Regimen for Glioblastoma Multiforme	Evaluating the possible adverse reactions recorded are analyzed, mainly including the number, incidence and severity of radiochemotherapy-related adverse reactions and immune-related adverse reactions (irAE) from the beginning of treatment to the progression of disease.; Include: Systemic reaction: such as dizziness, fatigue, bone or muscle pain, etc.; drug allergic reaction; Cytopenia caused by myelosuppression may lead to severe infection, bleeding, anemia, etc.; Gastrointestinal symptoms such as loss of appetite, nausea, vomiting, abdominal pain, diarrhea, constipation, fecal occult blood, gastrointestinal bleeding, etc.; Immune-related adverse reactions (irAE) : Pneumonia, including immune correlation immunity correlation colitis, correlation immune correlation hepatitis, nephritis, immune related endocrine diseases, immune correlation skin reactions and other immune system Related adverse reactions.	From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 21 days)
Secondary	To Evaluate the survival of the Integrated Treatment Regimen for Glioblastoma Multiforme	Using the RANO criteria as the efficacy evaluation criteria, multimodal MRI and 11C-MET PET/CT examination were performed to distinguish false progression, recurrence and radiation injury if necessary. MDT was discussed when necessary.; OS:Survival was measured from the start of treatment for 2 years or until death (from any cause within 2 years). Overall survival was estimated by planMeier. Patients who are still alive will be examined at the last contact visit.; See RANO Standard for specific standards.	From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 63 days)
Secondary	To Evaluate the efficacy of the Integrated Treatment Regimen for Glioblastoma Multiforme	Using the RANO criteria as the efficacy evaluation criteria, multimodal MRI and 11C-MET PET/CT examination were performed to distinguish false progression, recurrence and radiation injury if necessary. MDT was discussed when necessary.; PFS:Progression-free survival (PFS) was calculated from the date of SD after treatment until the first occurrence of disease progression. Progression-free survival was estimated by Haplan-Meier. Patients who are still alive and have no disease progression will be examined at the last visit/contact. Whether disease progression is due to the primary or metastases should be documented.ORR and quality of life.; See RANO Standard for specific standards.	From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 63 days)