Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme

NCT05589961 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: HebeiSH_GBM_V1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 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: 1. Systemic reaction: such as dizziness, fatigue, bone or muscle pain, etc.; 2. drug allergic reaction; 3. Cytopenia caused by myelosuppression may lead to severe infection, bleeding, anemia, etc.; 4. Gastrointestinal symptoms such as loss of appetite, nausea, vomiting, abdominal pain, diarrhea, constipation, fecal occult blood, gastrointestinal bleeding, etc.; 5. 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 Outcomes (2)

• To Evaluate the survival of the Integrated Treatment Regimen for Glioblastoma Multiforme

  From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 63 days)

• To Evaluate the efficacy of the Integrated Treatment Regimen for Glioblastoma Multiforme

  From first dose until 30 days after the last dose (up to approximately 2 years ) (Cycle length= 63 days)

Study Arms (1)

integrated treatment regimen(TRPP)

EXPERIMENTAL

Drug: TMZ

Interventions

TMZ DRUG

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.

Also known as: PD-1, RF

integrated treatment regimen(TRPP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

the Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Chunyan Li, Academician

  The Second Hospital of Hebei Medical University

  STUDY CHAIR

Central Study Contacts

Chunyan Li, Academician

CONTACT

0311-87064024; hebeichunyanli@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: October 21, 2022
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)