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TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00074334
Recruitment Status : Terminated (Drug company withdrawal of support for investigational agent in this indication.)
First Posted : December 11, 2003
Last Update Posted : October 21, 2009
National Cancer Institute (NCI)
Information provided by:
Pediatric Brain Tumor Consortium

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: TGFa-PE38 immunotoxin Procedure: conventional surgery Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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
Study Start Date : May 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Primary Outcome Measures :
  1. Maximum safe volume rate of TP-38 infused through three catheters (Stratum A) or through two catheters (Stratum B).
  2. Maximum tolerated infusion concentration of TP-38 infused through three catheters (Stratum A) or through two catheters (Stratum B).
  3. Toxicities of TP-38
  4. Post-infusion survival (phase II)

Secondary Outcome Measures :
  1. EGFR expression and phosphorylation (activity)
  2. Correlation of EGFR expression with tumor histology, tumor grade, tumor response (phase I and phase II) and survival and progression-free survival (phase II).
  3. Post-infusion progression-free survival (phase II)
  4. Objective response (phase II)

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed supratentorial malignant glioma

    • Recurrent or progressive disease
  • Amenable to gross total resection, clinically indicated partial resection, or biopsy
  • Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter

    • No tumor crossing midline

      • Tumors invading the corpus callosum that do not extend beyond to midline or into the contralateral hemisphere allowed
    • No more than 1 focus of tumor
    • No tumors involving the brainstem or cerebellum
    • No tumor dissemination (i.e., subependymal or leptomeningeal)
  • Must be on steroids ≥ 3 days prior to surgery
  • Must have received prior external beam radiotherapy (tumor dose at least 45 Gy) and completed therapy at least 8 weeks before study entry
  • No impending herniation, including midline shift greater than 0.5 cm
  • No requirement for immediate palliative treatment



  • 3 to 21

Performance status

  • Karnofsky 60-100% (patients over 16 years of age) OR
  • Lansky 60-100% (patients age 16 and under)

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3*
  • Hemoglobin at least 9 g/dL* NOTE: *Transfusion independent


  • ALT and AST less than 2.5 times upper limit of normal (ULN)
  • PT and PTT no greater than ULN


  • Creatinine less than 1.5 times normal OR
  • Glomerular filtration rate greater than 70 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 30 days after study participation
  • No uncontrolled seizures
  • No active infection requiring treatment
  • No unexplained febrile illness
  • No known or suspected allergies to local anesthetics
  • No systemic disease or other condition that may be associated with unacceptable anesthetic/operative risk and/or that would preclude study completion
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer


Biologic therapy

  • At least 8 weeks since prior hematopoietic stem cell transplantation


  • At least 6 months since prior polifeprosan 20 with carmustine implant (Gliadel® wafer)
  • At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and 2 weeks for vincristine)
  • At least 2 weeks since prior non-cytotoxic chemotherapy
  • No other prior intracerebral chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent steroids allowed


  • See Disease Characteristics
  • No prior focal radiotherapy (e.g., gamma knife radiosurgery, stereotactic radiosurgery, or brachytherapy)
  • No concurrent radiotherapy


  • Not specified


  • Recovered from prior therapy
  • At least 4 weeks since prior anticancer investigational agents
  • No prior localized antitumor therapy for malignant glioma
  • No other concurrent investigational agent
  • No other concurrent anticancer (including alternative anticancer medicines/treatment) agent or therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00074334

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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
Sponsors and Collaborators
Pediatric Brain Tumor Consortium
National Cancer Institute (NCI)
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Study Chair: Roger J. Packer, MD Children's Research Institute

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Responsible Party: James M. Boyett/PBTC Operations and Biostatistics Center Executive Director, Pediatric Brain Tumor Consortium Identifier: NCT00074334     History of Changes
Other Study ID Numbers: CDR0000344416
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009
Keywords provided by Pediatric Brain Tumor Consortium:
childhood high-grade cerebral astrocytoma
recurrent childhood cerebral astrocytoma
childhood oligodendroglioma
childhood supratentorial ependymoma
recurrent childhood ependymoma
recurrent childhood brain tumor
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Immunologic Factors
Physiological Effects of Drugs