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Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors

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.
ClinicalTrials.gov Identifier: NCT00104091
Recruitment Status : Completed
First Posted : February 23, 2005
Last Update Posted : May 23, 2011
Information provided by:

Study Description
Brief Summary:
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: TP-38 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection
Study Start Date : December 2004
Primary Completion Date : April 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
40 mL of TP-38 at a 100 nanograms/mL concentration
Drug: TP-38
TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.

Outcome Measures

Primary Outcome Measures :
  1. Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Efficacy parameters including time to progression, safety, and survival [ Time Frame: 26 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The patients must fulfill all the following criteria:

  • Previous histologically-confirmed diagnosis of primary GBM (glioblastoma multiforme, glioma grade 4 at time of first diagnosis).
  • Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous resection (surgical or biopsy) and radiation therapy.
  • Medically capable of undergoing the planned surgical gross total resection and the catheter placement.
  • Age ≥ 18.
  • Karnofsky Performance Status of ≥ 70%.
  • Life expectancy of ≥ 3 months.
  • Patients must already be taking or begin taking corticosteroids at a stable dose of 4 mg every 6 hours for at least 72 hours prior to catheter placement.
  • Patients must be capable of taking, or already taking, anticonvulsant medication.
  • Patients must have read, signed, and dated an informed consent according to ICH-GCP, the local regulatory requirement and the rules followed at each institution.

Exclusion Criteria:

Patients fulfilling any of the following criteria should not be enrolled in the study:

  • Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
  • Any form of brain radiation within 10 weeks of the start of the infusion.
  • Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
  • Prior intracavitary biologic response modifiers or monoclonal antibodies.
  • Uncontrolled seizures.
  • Bilateral or multifocal tumors.
  • Evidence of cerebral uncal herniation.
  • Midline brain shift on MRI scan of > 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.
  • Tumors involving the brainstem or cerebellum.
  • Diffuse subependymal or CSF disease.
  • Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrheic for at least 12 months to be considered non-childbearing.
  • Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.
  • Prior or concurrent investigational treatment within 30 days of study entry.
  • Active infection requiring treatment or having an unexplained febrile illness.
  • Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.
  • Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).
More Information

Responsible Party: Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00104091     History of Changes
Other Study ID Numbers: IXR-202-22-188
First Posted: February 23, 2005    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011

Keywords provided by Teva Pharmaceutical Industries:
Gross Total Resection
Convection Enhanced Delivery
Recurrent Glioblastoma Multiforme

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue