Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00002753
First received: November 1, 1999
Last updated: February 15, 2013
Last verified: February 2013

November 1, 1999
February 15, 2013
November 1991
April 2001   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002753 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas
PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas.

OBJECTIVES: I. Assess the toxic effects of intracystic administration of iodine-131-labeled anti-tenascin monoclonal antibody 81C6. II. Identify any objective therapeutic responses to this treatment in patients with recurrent cystic anaplastic gliomas.

OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6, 131I-81C6.

PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.

Interventional
Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Radiation: iodine I 131 monoclonal antibody 81C6
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
April 2001
April 2001   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic glioma with a recurrent cyst requiring aspiration for symptom control Measurable cystic lesion confirmed by contrast-enhanced CT or MRI At least 3 months since radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Negative pregnancy test Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic chemotherapy unless unequivocal evidence of tumor progression Endocrine therapy: Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry Radiotherapy: See Disease Characteristics Surgery: Not specified

Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002753
CDR0000064689, DUMC-1965-98-12R7, DUMC-1752-96-12R5, DUMC-1775-95-12R4, DUMC-1860-97-12R6, NCI-H96-0008
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Duke University
Duke University
Not Provided
Study Chair: Darell D. Bigner, MD, PhD Duke Cancer Institute
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP