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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004017
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Procedure: conventional surgery Radiation: iodine I 131 monoclonal antibody TNT-1/B Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: Treatment
Official Title: Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
Study Start Date : February 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA)
  • MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm^3

    • Recurrent GBM and AA must be documented by MRI after the most recent treatment and before any planned surgical debulking
  • At least 5 days since prior surgical debulking
  • No planned resection of newly diagnosed GBM before or during study
  • No bilateral noncontiguous gadolinium enhancing tumors
  • No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip
  • No more than 2 satellite lesions



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • WBC at least 3,000/mm^3


  • Hepatitis B surface antigen negative
  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN
  • Lactic dehydrogenase no greater than 3 times ULN
  • Prothrombin time no greater than 1.5 times ULN


  • Creatinine clearance at least 50 mL/min


  • No significant unstable cardiovascular disease
  • No New York Heart Association class III/IV heart disease
  • No evidence of myocardial infarction within the past 3 months


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Human antichimeric antibody (HACA) titer no greater than 48 ng/mL
  • No anatomical or physiological considerations that would preclude study participation
  • No active autoimmune disease, active infection, or traumatic injury requiring treatment
  • HIV negative


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers

Endocrine therapy:

  • Not specified


  • At least 8 weeks since prior external beam or gamma knife radiotherapy


  • See Disease Characteristics


  • At least 30 days since prior investigational treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004017

United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28207-1830
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Peregrine Pharmaceuticals
Study Chair: Terrence G. Chew, MD Peregrine Pharmaceuticals Identifier: NCT00004017     History of Changes
Other Study ID Numbers: CDR0000067235
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs