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| Sponsor: | Pediatric Brain Tumor Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00074334 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: TGFa-PE38 immunotoxin Procedure: conventional surgery |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: 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 |
| Enrollment: | 3 |
| Study Start Date: | May 2004 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| 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
Contacts and Locations| 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, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| 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 | |
| Study Chair: | Roger J. Packer, MD | Children's Research Institute |
More Information
| Responsible Party: | James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00074334 History of Changes |
| Other Study ID Numbers: | CDR0000344416, PBTC-013 |
| Study First Received: | December 10, 2003 |
| Last Updated: | October 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
childhood high-grade cerebral astrocytoma recurrent childhood cerebral astrocytoma childhood oligodendroglioma |
childhood supratentorial ependymoma recurrent childhood ependymoma recurrent childhood brain tumor |
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |
Immunotoxins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |