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Sponsors and Collaborators: |
Pediatric Brain Tumor Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074334 |
RATIONALE: The TP-38 toxin can locate tumor cells and kill them without harming normal cells. Giving TP-38 toxin directly into the tumor may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of TP-38 toxin administered directly into the brain and to see how well it works in treating young patients with recurrent or progressive supratentorial high-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: TGFa-PE38 immunotoxin Procedure: conventional surgery |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study Of A Recombinant Chimeric Protein Composed Of Transforming Growth Factor (TGF)-a And A Mutated Pseudomonas Exotoxin Termed PE38 (TP-38) In Pediatric Patients With Recurrent Or Progressive Supratentorial High Grade Gliomas |
Study Start Date: | May 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study. Patients in the phase I portion of the study are stratified according to the number of successfully placed catheters (3 catheters vs 2 catheters). Patients in the phase II portion of the study are stratified according to time of recurrence of high-grade glioma (first vs second or greater) and disease progression (yes or no).
Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients (in each stratum) receive escalating volumes followed by escalating concentrations of TP-38 until the maximum safe volume (MSV) and maximum tolerated infusion concentration (MTIC) are determined. The MSV and MTIC are defined as the volume and concentration preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 6-105 patients (6-60 for phase I and 45 for phase II) will be accrued for this study.
Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial malignant glioma
Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter
No tumor crossing midline
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, District of Columbia | |
Children's National Medical Center | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | |
Chicago, Illinois, United States, 60614 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 | |
United States, Texas | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |
Houston, Texas, United States, 77030-2399 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 |
Study Chair: | Roger J. Packer, MD | Children's Research Institute |
Investigator: | Robert Keating, MD | Children's Research Institute |
Study ID Numbers: | CDR0000344416, PBTC-013 |
Study First Received: | December 10, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00074334 History of Changes |
Health Authority: | United States: Federal Government |
childhood high-grade cerebral astrocytoma recurrent childhood cerebral astrocytoma childhood oligodendroglioma |
childhood supratentorial ependymoma recurrent childhood ependymoma recurrent childhood brain tumor |
Brain Neoplasms Immunologic Factors Astrocytoma Mitogens Brain Tumor, Childhood Oligodendroglioma |
Glioma Central Nervous System Neoplasms Immunotoxins Recurrence Ependymoma Nervous System Neoplasms |
Neoplasms Neoplasms by Site Immunologic Factors Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Neoplasms Pharmacologic Actions Immunotoxins Nervous System Neoplasms |