Glioblastoma Multiforme Clinical Trial
Official title:
Pilot Imaging Study to Assess the Distribution of IL13-PE38QQR Cytotoxin Infusions in Patients With Recurrent, Resectable, Supratentorial Malignant Glioma
The experimental anti-cancer drug IL13-PE38QQR, which is being developed for the treatment
of malignant brain tumors, is composed of parts of two proteins: the immune system cytokine
IL13 and a toxin from the bacterium Pseudomonas aeruginosa. The IL13 part of the drug binds
to another protein, the IL13 receptor, when this receptor is displayed on the outside
surface of cells. Cells with drug bound to the IL13 receptor take up the drug, and the toxin
part of the drug then kills those cells. Since brain tumor cells display the IL13 receptor,
they are potential targets that may be killed by this drug. This is a pilot study to
visualize the distribution of IL13-PE38QQR infused into and around brain tumor tissue before
and after surgical removal of the tumor in adult patients with recurrent malignant glioma.
Stored tumor tissue will be tested for presence of the receptor protein, which is required
for study entry. Eligible patients will then undergo biopsy to confirm the diagnosis of
recurrent malignant glioma. IL13-PE38QQR will be infused for 96 hours into and around tumor
tissue through catheters that have been placed surgically. For the first 48 hours the drug
will be mixed with a radioactive tracer, so that the distribution of the drug can be
followed by a type of scanning called SPECT. Surgery to remove the tumor will be performed
approximately 15 days after the end of the infusion. Catheters will again be placed
surgically, and IL13-PE38QQR will be infused a second time for 96 hours. Radioactive tracer
will be included in the infusion for the first 48 hours. For both infusions, SPECT scans
will be taken at 6, 24, and 48 hours after the start of infusion. MRI scans will be taken
within 90 minutes of the 24 and 48 hour SPECT scans. Patients will be followed closely with
further scans and laboratory tests until completion of the study approximately 58 days after
completion of the second infusion.
OBJECTIVES:
- 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
above.
- 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.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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