Status:
UNKNOWN
Niraparib Combined With Radiotherapy in rGBM
Lead Sponsor:
Tianjin Huanhu Hospital
Conditions:
Recurrent Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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
- KPS≥60
- 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/µL; platelets ≥100,000/µL; 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04715620
Start Date
January 1 2021
End Date
January 1 2023
Last Update
January 20 2021
Active Locations (1)
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1
Tianjin Huanhu Hosptal
Tianjin, Tianjin Municipality, China, 300350