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Pilot Imaging Study to Assess the Distribution of IL13-PE38QQR Cytotoxin Infusions in Patients With Recurrent, Resectable, Supratentorial Malignant Glioma

Phase 1
18 Years
Not Enrolling
Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Oligoastrocytoma

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Trial Information

Pilot Imaging Study to Assess the Distribution of IL13-PE38QQR Cytotoxin Infusions in Patients With Recurrent, Resectable, Supratentorial Malignant Glioma


- Assess the distribution of IL13-PE38QQR following continuous infusion via catheter(s)
into recurrent malignant glioma prior to surgical resection and a continuous infusion
via catheter(s) into brain tissue adjacent to tumor resection site after surgical
resection. 123I-HSA tracer will be used as a surrogate for study drug distribution.

- Determine the toxicities associated with administration of IL13-PE38QQR as described

- Assess the effect on distribution of IL13-PE38QQR of varying the catheter type (up to
3) and flow rate per catheter, keeping the total flow rates constant, for the pre- and
post-resection infusions.

OUTLINE: This is a pilot study to assess the distribution of IL13-PE38QQR delivered by
intratumoral infusion prior to surgical resection and by interstitial infusion into tissue
surrounding the resection site (peritumoral) after surgical resection. Prior to resection,
catheters will be placed in the region of the solid contrast-enhancing tumor component. The
volume of infusion, the duration of infusion, and the concentration of IL13-PE38QQR in the
infusate will be fixed. For the post-resection infusion, catheters will be placed
peritumorally into areas at greatest risk for residual or infiltrating tumor. The
post-resection volume of infusion, the duration of infusion, and the concentration of
IL13-PE38QQR in the infusate will be fixed. For the first 48 hours of each infusion,
IL13-PE38QQR will be prepared with 123I-HSA tracer as the surrogate for distribution of
study drug. The type and number of catheters utilized to deliver the pre- and post-surgery
infusions will vary. To maintain a fixed total volume of infusate over 96 hours, the rate
of infusion will vary depending upon the number of catheters utilized. Up to three
different catheter types will be tested. However, only the same, single type of catheter
will be utilized for the pre- and post-resection infusions for a given patient.

To allow assessment of the distribution of the infused material, the first 48 hours of both
the pre- and post-resection infusions will utilize 123I-HSA in the infusate. For the last
48 hours of both infusions, the 123I-HSA will be replaced by non-labeled HSA. The
distribution of the 123I-HSA tracer will be measured by Single-Photon Emission Computed
Tomography (SPECT) scanning.

PROJECTED ACCRUAL: Up to 18 patients will be enrolled at a single site.

Inclusion Criteria


- Archival tumor sample must express IL13Rα2 by immuno-histochemistry (IHC) analysis

- Must have prior histologic diagnosis of supratentorial malignant glioma (Grade 3 or
4), including glioblastoma multiforme, anaplastic astrocytoma, anaplastic
oligodendroglioma, or mixed oligoastrocytoma (excludes glioma of unknown grade).
Patients with clinical/radiographic diagnosis of malignant glioma may be registered
pending histologic confirmation.

- Must have undergone prior surgical resection and received external beam radiotherapy
with at least 48 Gy tumor dose, completed at least 8 weeks prior to study

- Must have recurrent or progressive supratentorial malignant glioma compared with a
previous diagnostic study

- Baseline tumor measured within 2 weeks prior to study entry

- Stereotactic biopsy at study entry must confirm the presence of glioma (malignant,
unless previously documented)

- Recurrent or progressive tumor must have a solid contrast-enhancing region at least
1.0 cm and no more than 5.0 cm in maximum diameter. One satellite lesion is permitted
if separated by 3 cm or less from the primary mass.


- Age 18 and over

- Karnofsky Performance Score of at least 70

- Absolute neutrophil count at least 1500/mm^3

- Hemoglobin at least 10 gm/dL

- Platelet count at least 100,000/mm^3

- PT and aPTT within institutional limit of normal

- Must be candidate for re-operation

- Must have recovered from toxicity of prior therapy. Minimum intervals required: at
least 6 months after approved intratumoral chemotherapy (e.g. carmustine wafer), at
least 6 weeks after nitrosourea-containing chemotherapy, at least 4 weeks after any
investigational agent or any other cytotoxic chemotherapy, at least 2 weeks after
vincristine or non-cytotoxic chemotherapy

- Must practice an effective method of birth control during the study

- Must understand the investigational nature of this study and its potential risks and
benefits, and sign an approved written informed consent prior to performance of any
study-specific procedure

- No patients with tumor crossing the midline (tumor involving corpus callosum is
permitted if not crossing midline), more than two foci of tumor, or non-parenchymal
tumor dissemination (e.g. subependymal or leptomeningeal)

- No patients with impending herniation (e.g. midline shift greater than 1.0 cm),
uncontrolled seizures, or requirement for immediate palliative treatment

- No patients who have received localized therapy for glioma, e.g. focal
single-fraction radiotherapy, brachytherapy, or intracerebral infusion of
chemotherapy or cytotoxin

- No patients who are receiving any concurrent chemotherapy or any other
investigational agent (corticosteroids are permitted)

- No patients with a known allergy to iodine or to contrast medium that may be utilized
in scans required by this protocol

- Female patients must not be pregnant or breast-feeding

- No patients unwilling or unable to follow protocol requirements

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

July 2007

Related Keywords:

  • Malignant Glioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Mixed Oligoastrocytoma
  • CNS neoplasms
  • Brain neoplasms
  • neurosurgery
  • intralesional infusion
  • recombinant proteins
  • immunotoxins
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma



Duke University Medical Center Durham, North Carolina  27710