IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma
This study has been completed.
Sponsor:
Insys Therapeutics Inc
Information provided by:
Insys Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT00089427
First received: August 5, 2004
Last updated: June 30, 2011
Last verified: April 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme Anaplastic Astrocytoma Oligoastrocytoma |
Drug: IL13-PE38QQR Procedure: Surgery for placement Procedure: Radiation therapy Drug: Temozolomide with radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Convection Enhanced Delivery (CED) of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma |
Resource links provided by NLM:
Further study details as provided by Insys Therapeutics Inc:
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2004 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089427
Locations
| United States, California | |
| University of California San Francisco - Dept. of Neurological Surgery | |
| San Francisco, California, United States, 94143 | |
| United States, North Carolina | |
| Carolina Neurosurgery & Spine Assoc. | |
| Charlotte, North Carolina, United States, 28204 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland Clinic Foundation Department of Neurological Surgery | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| University of Texas M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia Health Systems - Department of Neurological Surgery | |
| Charlottesville, Virginia, United States, 22908 | |
Sponsors and Collaborators
Insys Therapeutics Inc
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00089427 History of Changes |
| Obsolete Identifiers: | NCT00105014 |
| Other Study ID Numbers: | IL13PEI-106-R01 |
| Study First Received: | August 5, 2004 |
| Last Updated: | June 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Insys Therapeutics Inc:
|
brain tumor malignant glioma brain neoplasm central nervous system surgery resection temozolomide infusion |
glioblastoma multiforme anaplastic astrocytoma oligoastrocytoma Temodar radiation convection-enhanced delivery GBM |
Additional relevant MeSH terms:
|
Astrocytoma Glioblastoma Glioma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013