NCT00004017

Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma

Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors. PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.

Detailed description

OBJECTIVES: * 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 additional treatment. 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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
PROCEDURE	conventional surgery
RADIATION	iodine I 131 monoclonal antibody TNT-1/B

Timeline

• Start date: 2000-02-01
• First posted: 2003-01-27
• Last updated: 2009-02-09

Locations

4 sites across 1 country: United States