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Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

NCT05589961•The Second Hospital of Hebei Medical University

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+12 more criteria

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;
+1 more criteria

Locations (1)

the Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

July 1, 2024

Completion Date

July 1, 2024

Last Updated

October 21, 2022

Enrollment

ESTIMATED participants

Conditions

Glioblastoma Multiforme

Interventions

TMZ

DRUG

Contacts

Chunyan Li, Academician

CONTACT

0311-87064024 hebeichunyanli@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

Inclusion Criteria

Exclusion Criteria

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