KCT0006561
Recruiting
未知
A phase 2, single-center, open-label, single-arm study to evaluate the efficacy and safety of GX-I7 in combination with bevacizumab in recurrent glioblastoma (GBM) patients
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Subjects (or a legally acceptable representative, if applicable) must be willing and able to provide written informed consent/assent for the trial.
- •2\)Age \= 19 years
- •3\)Histologically diagnosed glioblastoma patients who have been confirmed the progression of disease after attempting standard therapy (RT/CCRT and/or adjuvant chemotherapy (TMZ)),
- •a.For subjects who have had surgery after recurrence, residual and measurable lesions after surgery are not required, but surgery must have confirmed the recurrence, and the post\-surgery MRI should be available within 48 hours of surgery. Screening is possible at least 2 weeks after surgery and subjects must be fully recovered from surgery. The administration of investigational product is possible after 28 days of the last surgery (a major surgery requiring general anesthesia, including biopsy and surgical resection)
- •b.For subjects who did not operate after recurrence, the recurrent disease should be at least one\-dimensionally measurable contrast\-enhancing lesion with clearly defined margins by MRI scan with minimum diameters of 100 mm, visible on 2 or more axial slices 5 mm apart, based on MRI scan measured within 2 weeks before the enrollment
- •4\)Karnofsky Performance Status; KPS \= 60
- •5\)Life expectancy \> 12 weeks
- •6\)Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the screening period
- •a.Absolute neutrophil count (ANC) \= 1,500 cells/µL
- •b.Hemoglobin \= 9 g/dL
Exclusion Criteria
- •1\)Malignancies other than disease under study within 5 years prior to the first dose of study drug, except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ)
- •2\)Subjects who have received bevacizumab or other VEGF inhibitors prior to study participation
- •3\)Body Mass Index (BMI) \= 30 kg/m2
- •4\)Subjects confirmed intracranial hemorrhage with non\-contrast CT or MRI
- •5\)Bleeding diathesis or coagulopathy
- •6\)Clinically significant cardiovascular disease, such as cerebrovascular accidents or myocardial infarctions within 6 months prior to enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater CHF, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with study treatment
- •7\)History of arterial or venous thromboembolism 6 months prior to study participation
- •8\)Uncontrolled hypertension (blood pressure \= 150/90 mmHg with appropriate antihypertensive therapy)
- •9\) History of hypertensive crisis or hypertensive encephalopathy
- •10\)Subjects receiving therapeutic anticoagulation (except low molecular weight heparin or warfarin)
Outcomes
Primary Outcomes
Not specified
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