Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma

NCT00024570 | Completed Phase 1

• 3 other identifiers: IL13PEI-001NCI-NABTT-9903JHU-NABTT-9903
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief Summary

IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the IL13 receptors was shown to be highly specific for human glioma cells. IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly into the malignant brain tumors of patients to determine the dose of drug these patients can tolerate. After that, the selected dose will be studied to give an estimate of the response rate, response duration, time to response, and survival after infusing that dose of IL13-PE38QQR into the recurrent malignant glioma.

Conditions

Malignant Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Mixed Oligoastrocytoma

Keywords

neurosurgery, craniotomy; convection-enhanced delivery; CNS interstitial infusion; recombinant toxins; malignant glioma, recurrent; catheter, stereotaxic; intratumoral therapy; positive pressure microinfusion

Interventions

IL13-PE38QQR DRUG

targeted fusion protein therapy PROCEDURE

surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Disease Characteristics * Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic diagnosis of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma, glioblastoma multiforme and malignant mixed oligoastrocytoma. (Note: If diagnosis is dependent upon the Day 0 biopsy, pathology must be confirmed prior to start of IL13PE-38QQR infusion). * Must have received cranial radiotherapy, with tumor dose of at least 48 Gy, completed at least 12 weeks prior to study entry. * Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with a previous study. The baseline tumor measurements must be determined within 2 weeks prior to study entry. The tumor must have a solid portion at least 1.0 cm but not more than 5.0 cm in maximum diameter. A maximum of one satellite lesion is permitted, if separated by less than 3 cm from the primary mass. * Stereotaxic biopsy at study entry must confirm the presence of glioma. Patient Characteristics * Age 18 or greater. * Karnofsky Performance Score must be at least 60. * Hematologic status: Absolute neutrophils at least 1,500/mm\^3; Hemoglobin at least 10 gm/dL; Platelets at least 100,000/mm\^3; PT \& PTT less than or equal to the upper limit of normal. * Hepatic Status: Transaminases not more than 2.5 x upper limit of normal; Total Bilirubin not more than 2.0 mg/dL. * Must have recovered from toxicity of prior therapy; at least 6 weeks elapsed since receiving nitrosourea-containing chemotherapy and 3 weeks since receiving any other chemotherapy. * Must practice an effective method of birth control during the study. * Must understand the investigational nature of this study and its potential risks and benefits, and must sign informed consent. * No patients with more than two foci of tumor, tumor crossing the midline, or leptomeningeal tumor dissemination. * No patients with impending herniation, spinal cord compression, or uncontrolled seizures. * No patients who have received any localized antitumor therapy for the malignant glioma, either intralesional chemotherapy or focal radiotherapy (i.e. any form of stereotaxic RT or brachytherapy). * No patients who are receiving concurrent chemotherapy or another investigational agent. * No patients with prior or concurrent malignancy. (Patients with curatively treated carcinoma-in-situ or basal cell skin carcinoma OR who have been free of disease for at least 5 years are eligible). * Female patients must not be pregnant or breast-feeding.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• INSYS Therapeutics Inc: lead

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma; Astrocytoma; Recurrence

Interventions

IL13-PE38; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Weingart, MD

  The Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 20, 2001
• First Posted: September 21, 2001
• Study Start: November 1, 2000
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

US (8)