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. Identifier: NCT00071539
Recruitment Status : Completed
First Posted : October 29, 2003
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

October 28, 2003
October 29, 2003
January 20, 2012
October 2003
January 2006   (Final data collection date for primary outcome measure)
Survival [ Time Frame: 28 weeks ]
% patients alive
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Complete list of historical versions of study NCT00071539 on Archive Site
Time to progression (TTP) [ Time Frame: 28 weeks ]
An independent review committee will review MRI scans and will be blinded to the dose each patient received.
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Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
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Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Recurrent Glioblastoma Multiforme
  • Drug: TP-38
    Recombinant chimeric protein
    Other Name: immunotoxin
  • Drug: TP38
    recombinant chimeric protein
    Other Name: immunotoxin
  • Experimental: TP38 50 ng/mL
    Intervention: Drug: TP-38
  • Experimental: TP38 100 ng/mL
    Intervention: Drug: TP38
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2006
January 2006   (Final data collection date for primary outcome measure)

Inclusion criteria:

The patients must fulfill all the following criteria:

  • Previous histologically-confirmed diagnosis of primary GBM (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 amenorrhoeic for at least 12 months to be considered of 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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United States
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Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
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Teva Pharmaceutical Industries
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP