Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma

NCT05201326 | Unknown Phase 1

• 1 other identifier: RJHGBMrRT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. The study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the treatment of recurrent GBM.

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (1)

• serious adverse events (SAE)

  Clinical safety

  From baseline to 28 days after the end of treatment

Secondary Outcomes (2)

• overall survival

  From the beginning of treatment to death or the last follow-up, approximately 24 months

• progression free survival

  From the start of treatment to the date of disease progression or death, up to approximately 24 months

Other Outcomes (2)

• Quality of life score

  Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months

• Cognitive function

  Receive once every two months until you cannot tolerate toxicity or PD, up to about 24 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

irinotecan + bevacizumab + Re-radiotherapy

Drug: Bevacizumab，Irinotecan and Re-radiotherapy

Interventions

Bevacizumab，Irinotecan and Re-radiotherapy DRUG

All patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy .

Treatment arm

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 initial diagnosis confirmed by histopathology is World Health Organization WHO grade 4 glioma;
• Surgery, radiotherapy, chemotherapy, and adjuvant chemotherapy (Stupp plan) are performed after the initial diagnosis, and recurrence according to the evaluation of neurotumor response (RANO) criteria and/or confirmed by histopathology;
• The expected survival period is ≥3 months;
• Age between 18 and 70 years old;
• KPS score (KPS) ≥ 70, able to take care of most of life, but occasionally need help from others;
• There are measurable lesions on the T1 enhancement sequence of the head MRI;
• Hematopoietic function: hemoglobin ≥90g/L, platelets ≥90×109/L, white blood cells ≥4×109/L (previous chronic anemia 80-90 g/L or previous low white blood cell level 3-4×109/L Or thrombocytopenia 80-90×109/L, but KPS 70-100 can be considered for admission) (The range of normal values can be fine-tuned due to the different standards of tertiary first-class hospitals);
• Liver function: ALT and AST\<1.5 times of high normal (ULN), bilirubin\<1.5×ULN;
• Sign the informed consent form;
• Agree to participate in follow-up actions.

You may not qualify if:

• Other invasive malignant tumors;
• Re-irradiation after receiving recurrence in the past;
• Recurrence more than 3 times or evidence that there is a subdural recurrence disease or a tumor with a maximum diameter of more than 6 cm;
• Treat with vascular endothelial growth factor (VEGF) or VEGFR inhibitor or irinotecan in advance;
• Pregnant or nursing mothers;
• Participate in other tests after diagnosis of recurrence;
• According to CTCAE5.0 standard classification of patients with bleeding above grade 3;
• Symptomatic peripheral vascular disease;
• Known allergy to bevacizumab or irinotecan;
• Patients who are treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; under the premise that the prothrombin time international normalized ratio (INR) is ≤1.5, the use of small doses of Huafa for preventive purposes is allowed Farin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);
• Abnormal blood coagulation function, bleeding tendency (such as active peptic ulcer) or receiving thrombolysis or anticoagulation therapy;
• Arterial/venous thrombotic events that occurred within 6 months before the first medication, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
• Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification\>1.0 g;
• Long-term unhealed wounds or fractures;
• Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poor arrhythmia control (including men with QTc interval ≥450 ms, women ≥470 ms); according to NYHA standards, III to Grade IV insufficiency or color Doppler ultrasonography of the heart shows that the left ventricular ejection fraction (LVEF) is less than 50%;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, 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

• Jiayi Chen, MD

  Ruijin Hospital

  STUDY DIRECTOR

Central Study Contacts

fei xu, MD

CONTACT

18964152276; xf11976@rjh.com.cn

Yunsheng Gao, MD

CONTACT

gys11856@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Radiation Oncology

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 21, 2022
• Study Start: December 22, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2024
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)