Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
- Determine the median time to disease progression in patients with newly diagnosed
unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic
astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.
- Determine the median survival time of these patients treated with this regimen.
- Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic,
hematologic, and biochemical profiles in these patients.
- Confirm the maximum tolerated dose of this regimen in these patients.
- Optimize the drug delivery of this regimen in these patients.
- Assess the response of these patients in terms of MRI measured gadolinium enhanced
tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last
dose of study drug.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed.
One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over
approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each
will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the
infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial
response, minimal response, or stable disease repeat the above treatments during week 9.
Patients with complete response, progressive disease, or unacceptable toxicity receive no
Patients are followed every month until disease progression. All patients regardless of
disease progression or retreatment are followed at 36 weeks.
PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable
glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with
recurrent anaplastic astrocytoma) will be accrued for this study.
Primary Purpose: Treatment
Terrence G. Chew, MD
United States: Federal Government
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|Carolina Neurosurgery and Spine Associates||Charlotte, North Carolina 28207-1830|
|Temple University||Philadelphia, Pennsylvania 19140|