Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma

NCT00378235 | Withdrawn Phase 1

• 2 other identifiers: IL13PEI-151NCI Protocol No.: PBTC-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

Conditions

Recurrent Malignant Glioma

Keywords

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

Interventions

IL13-PE38QQR DRUG

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

-Disease Characteristics- Must be at least 3 years but not more than 21 years of age. Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic diagnosis of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma, mixed anaplastic astrocytoma, or glioblastoma multiforme. Must have radiographic evidence of recurrent or progressive supratentorial malignant glioma compared with a prior imaging study. The baseline tumor measurements must be determined within 2 weeks prior to study entry. The tumor must have a solid component at least 1.0 cm in diameter. Gross total resection must be planned, with the intent of removing all contrast-enhancing components of the tumor. Must have received external beam radiotherapy, with tumor dose of at least 48 Gy; and must be completed at least 8 weeks prior to study entry. -Patient Characteristics- Karnofsky Performance Score for patients older than 16 years, or the Lansky Performance Scale for patients 16 years old or younger, must be at least 60. Hematologic status: Absolute neutrophils at least 1,500/mm3; Hemoglobin at least 10 gm/dL (transfusion independent); Platelets at least 100,000/mm3 (transfusion independent); PT \& aPTT less than or equal to the institutional upper limit of normal. Must have recovered from toxicity of prior therapy: at least 6 months after Gliadel® wafer; at least 8 weeks after hematopoietic stem cell transplant; at least 4 weeks after any cytotoxic chemotherapy or any systemic investigational agent; at least 6 weeks after nitrosoureas; at least 2 weeks after vincristine or non-cytotoxic chemotherapy. Patient's legal guardian must understand the investigational nature of this study and its potential risks and benefits; must sign informed consent. No pregnant or breast-feeding patients. All patients of child-bearing age, male and female, must practice an effective method of birth control during the study. No patients with multi-focal tumor not amenable to gross total resection or tumor dissemination (subependymal or leptomeningeal). No patients with clinically significant increased intracranial pressure (e.g., impending herniation) uncontrolled seizures, or requirement for immediate palliative treatment. No patients who received any localized antitumor therapy for the malignant glioma, either intracerebral chemotherapy (other than Gliadel®) or focal radiation therapy (e.g., stereotactic radiosurgery or brachytherapy). No patients who are receiving concurrent chemotherapy (other than steroids) or any other investigational agent. No patients unwilling to follow protocol requirements.

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
• Pediatric Brain Tumor Consortium (PBTC), St. Jude Children's Research Hospital: collaborator

Study Sites (10)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Dana-Farber Cancer Institute-Dept of Pediatric Oncology

Boston, Massachusetts, 02215, United States

Location

Duke University Medical Center-Dept. of Pediatrics, Medicine & Surgery

Durham, North Carolina, 27710, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38014, United States

Location

Baylor College of Medicine-Dept of Pediatrics

Houston, Texas, 77030, United States

Location

Children's Hospital & Regional Medical Center

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Glioma; Recurrence

Interventions

IL13-PE38

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

• Anuradha Banerjee, MD, MPH

  University of California at San Francisco

  PRINCIPAL INVESTIGATOR

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 18, 2006
• First Posted: September 19, 2006
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

US (10)