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A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-4(38-37)-PE38KDEL (IL-4 Toxin) for the Treatment of Recurrent Malignant Astrocytoma (NCT00003842)

RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma. PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in treating patients who have recurrent malignant astrocytoma.
  • Biological: interleukin-4 PE38KDEL cytotoxin
    • Drug: isolated perfusion
      • Procedure: surgical procedure
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        OBJECTIVES: I. Determine the maximum tolerated dose of intratumorally infused IL-4(38-37)-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma. II. Determine the safety of this regimen in these patients. III. Determine preliminarily any efficacy of this regimen in these patients.

        OUTLINE: This is a dose escalation, multicenter study. Patients undergo a stereotactic biopsy under MR/CT guidance. Catheters are then placed into the tumor under stereotactic guidance. The catheter is filled with IL-4(38-37)-PE38KDEL immunotoxin (IL-4 toxin), with infusion beginning 24 hours after catheter insertion. The IL-4 toxin is infused over 4 days. The catheter is removed 45 minutes after the infusion is completed and a MR scan is performed. Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding the dose at which 2 of 3 patients experience dose limiting toxicity. Patients are followed every 4 weeks for 16 weeks, then every 8 weeks for up to 3 years.

        PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

        10 locations

        United States (10)
        • University of Southern California, Healthcare Consultation Center
          Los Angeles, California, United States, 90033
        • UCSF Cancer Center and Cancer Research Institute
          San Francisco, California, United States, 94115-0128
        • Neuro-Oncology Service
          San Francisco, California, United States, 94143-0372
        • John Wayne Cancer Institute
          Santa Monica, California, United States, 90404
        • Laboratory of Molecular Biology
          Bethesda, Maryland, United States, 20892
        • Food and Drug Administration
          Rockville, Maryland, United States, 20857
        • St. Louis University Health Sciences Center
          Saint Louis, Missouri, United States, 63110-0250
        • Herbert Irving Comprehensive Cancer Center
          New York, New York, United States, 10032
        • Charlotte Neurosurgical Associates
          Charlotte, North Carolina, United States, 28207-1830
        • Barrett Cancer Center, The University Hospital
          Cincinnati, Ohio, United States, 45219
        Status:
        unknown
        Type:
        Interventional
        Phase:
        Start:
        28 February, 1999
        Updated:
        16 December, 2013
        Participants:
        30
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