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
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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|Duke University Medical Center||Durham, North Carolina 27710|