A Phase 2 interventional study of ADV-TK/GCV and Surgery in Malignant Glioma of Brain and Glioblastoma, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-25.
Sponsored by Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment
Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 47 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.
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ADV-TK was administered via intraarterial cerebral infusion. Systemic GCV therapy was delivered at a dose of 5mg/kg intravenous, every 12 h at 36 hours after ADV-TK therapy.
Biological: ADV-TK/GCV
Patients received surgery or systemic chemotherapy or palliative care.
Procedure: Surgery · Drug: systemic chemotherapy
gene therapy
The primary end point was 6-month progression-free survival rate (PFS-6)
Time frame: 6 months
progression-free survival (PFS)
Time frame: 3 years
overall survival (OS)
Time frame: 3 years
safety
Time frame: 1. at the time during treatments; 2. at 6-month; 3. at the end of 1-year following-up; 4. at the end of 2-year following up; 5. at the time the patient censored.
clinical benefit
the rate of complete response, plus partial response, plus stable disease
Time frame: at the end of 2nd ADK-TK/GCV therapy
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Huazhong University of Science and Technology