Niraparib Combined With Radiotherapy in rGBM

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    30
  • sponsor
    Tianjin Huanhu Hospital
Updated on 2 February 2021

Summary

Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. After enrollment, patients were given niraparib 300mg/day (body weight 77Kg and baseline platelet count 150,000/L) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/L), combined with radiotherapy (total dose 55Gy), follow-up Time 1 year. Until the patient has disease progression or intolerance or voluntarily withdraw from the study.

Details
Condition Recurrent Glioblastoma
Treatment Niraparib
Clinical Study IdentifierNCT04715620
SponsorTianjin Huanhu Hospital
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sign a written informed consent form before conducting any research related procedures
Male or female aged between 18 and 70
Histologically confirmed WHO classification of recurrent glioblastoma grade IV
The expected survival time is more than 6 months
Able to receive radiotherapy again
KPS60
Can swallow and maintain oral medication
In the past month, no more than 3 grand epileptic seizures per week
Good organ function, including: Bone marrow function: neutrophil count 1500/L; platelets 100,000/L; hemoglobin 10g/dL; Liver function: total bilirubin 1.5 times the upper limit of normal or direct bilirubin 1.0 times the upper limit of normal; AST and ALT 2.5 times the upper limit of normal; Renal function: serum creatinine 1.5 times the upper limit of normal value, or creatinine clearance 60mL/min (calculated according to Cockcroft-Gault formula)
Ability to follow the plan
Any previous toxicity of chemotherapy has returned to CTCAE level 1 or baseline level, except for sensory neuropathy or alopecia with stable symptoms CTCAE level 2

Exclusion Criteria

Those who are known to be allergic to niraparib or the active or inactive ingredients of drugs with similar chemical structure to niraparib
Those who have previously received PARP inhibitor therapy
Have received major surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered after surgery or received chemotherapy
Received palliative radiotherapy with> 20% bone marrow 1 week before enrollment
The patient has previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
Suffer from serious or uncontrolled diseases, including but not limited to
Uncontrollable nausea and vomiting, inability to swallow study drugs, any
gastrointestinal diseases that may interfere with drug absorption and
metabolism; active viral infections such as human immunodeficiency virus
hepatitis B, hepatitis C, etc.; uncontrolled ventricular Arrhythmia
myocardial infarction in the last 3 months; uncontrolled grand mal seizures
unstable spinal cord compression, superior vena cava syndrome, or other mental
disorders that affect the patient's informed consent; immunodeficiency (except
splenectomy) Or other researchers believe that it may expose patients to high-
risk toxic diseases; hypertension that cannot be controlled by drugs; and
manifestations of intracranial hypertension, intracranial hemorrhage, and
intracranial infarction caused by any reason
Patients with distant metastasis
Any past or current disease, treatment, or laboratory abnormality that may interfere with the results of the study, affect the patient's full participation in the study, or the investigator believes that the patient is not suitable for participating in the study; the patient must not be allowed within four weeks before the start of the study drug treatment Receive platelet or red blood cell transfusion
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