IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1 study in patients with newly diagnosed malignant glioma is designed to determine the highest dose of IL13-PE38QQR that can be safely administered by Convection Enhanced Delivery (CED) to the area around the tumor site after the tumor is surgically removed (resection). In addition, the patient will receive radiation therapy and may or may not be treated with oral temozolomide.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INSYS Therapeutics Inc
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• Patients must be ≥18 years old.

• Patients must have undergone a gross total resection of the solid contrast-enhancing lesion(s) > 1.0 cm in diameter.

• Patients must be able to have catheters placed within 14 days of tumor resection (including a planned Gross Total Resection following an initial biopsy or subtotal resection)

• Patients must have histopathologic confirmation of malignant glioma from resection specimen. Diagnosis must be consistent with either GBM, AA, or malignant mixed OA.

• Patients must be in adequate general condition and meet the following criteria:

• a. Karnofsky Performance Scale score ≥ 70

• b. Adequate hematologic status:

• Absolute neutrophil count ≥ 1,500/mm³

• Hemoglobin ≥ 10 gm/dL

• Platelets ≥ 100,000/mm³

• PT & aPTT within institutional limits of normal

• Female patients must not be pregnant or breast-feeding.

• Patients must practice an effective method of birth control during the study and for 60 days beyond the last day of infusion.

• Patients must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure.

Exclusion Criteria:

• Patients with residual contrast-enhancing tumor crossing the midline, multifocal tumor not amenable to gross total resection or non-parenchymal tumor dissemination (e.g., subependymal or leptomeningeal).

• Patients with clinically significant increased ICP (e.g., impending herniation), uncontrolled seizures or requirement for immediate palliative treatment.

• Patients who have received any prior anti-tumor treatment (other than corticosteroids) including any investigational agents.

• Patients with any metallic prosthesis that would prevent MRI and/or MRS scanning procedures of the brain.

• Patients unwilling or unable to follow protocol requirements.