ADV-TK Improves Outcome of Recurrent High-Grade Glioma (HGG-01)

Huazhong University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Glioblastoma; Malignant Glioma of Brain

Treatments: Drug: systemic chemotherapy; Procedure: Surgery; Biological: ADV-TK/GCV

Study type: Interventional

Funder types: Other

Identifiers

NCT00870181

2009HGG-01

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed WHO grades 3 to 4 malignant glioma
• Diagnosed recurrence or progression by clinical or radiological evidence
• Fit for intraarterial infusion and intravenous chemotherapy
• Adequate hepatic, renal, and hematologic function.
• Legal age ≥18 years
• Life expectancy ≥12 weeks
• Eastern Cooperative Oncology Group performance (ECOG) ≥2
• Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities.

Exclusion criteria

• Active pregnancy
• Prior gene therapy
• Second primary tumor
• Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections
• Requiring treatment with warfarin or any other anticoagulants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

ADV-TK/GCV

Experimental group

Description:

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.

Treatment:

Biological: ADV-TK/GCV

Control group

Active Comparator group

Description:

Patients received surgery or systemic chemotherapy or palliative care.

Treatment:

Procedure: Surgery

Drug: systemic chemotherapy