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Sponsored by: |
Peregrine Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004017 |
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 |
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Brain and Central Nervous System Tumors |
Drug: iodine I 131 monoclonal antibody TNT-1/B Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | February 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm^3
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study Chair: | Terrence G. Chew, MD | Peregrine Pharmaceuticals |
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: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004017 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Recurrence Antibodies, Monoclonal Brain Neoplasms Neuroectodermal Tumors Antibodies Glioblastoma multiforme |
Neoplasms, Germ Cell and Embryonal Iodine Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |