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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00104091
First Posted: February 23, 2005
Last Update Posted: May 23, 2011
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.
Information provided by:
Teva Pharmaceutical Industries
  Purpose
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.

Condition Intervention Phase
Glioblastoma Multiforme Drug: TP-38 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

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

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

Estimated Enrollment: 56
Study Start Date: December 2004
Study Completion Date: June 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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
Criteria

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).
  Contacts and Locations
No Contacts or Locations Provided
  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 Submitted: February 22, 2005
First Posted: February 23, 2005
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:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue