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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004017
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: March 2003
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: February 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • See Disease Characteristics

Other:

  • At least 30 days since prior investigational treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004017

Locations
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
Investigators
Study Chair: Terrence G. Chew, MD Peregrine Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004017     History of Changes
Other Study ID Numbers: CDR0000067235, PEREGRINE-TNT9802, MUSC-7993, PEREGRINE-BB-IND-7344, TCLONE-BB-IND-7344, TCLONE-TNT9802, NCI-G99-1560
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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:
Astrocytoma
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014