Status:
COMPLETED
IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Glioblastoma Multiforme
Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This is a Phase I clinical trial of experimental drug IL13-PE38QQR (Study Drug) in patients with newly diagnosed malignant glioma. IL13-PE38QQR is a tumor-targeting agent administered by a continuous ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00089427
Start Date
July 1 2004
Last Update
July 4 2011
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California San Francisco - Dept. of Neurological Surgery
San Francisco, California, United States, 94143
2
Carolina Neurosurgery & Spine Assoc.
Charlotte, North Carolina, United States, 28204
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Cleveland Clinic Foundation Department of Neurological Surgery
Cleveland, Ohio, United States, 44195