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
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Radiation: iodine I 131 monoclonal antibody 81C6
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS

Resource links provided by NLM:


Further study details as provided by Duke University:

Estimated Enrollment: 6
Study Start Date: November 1991
Study Completion Date: April 2001
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT00002753

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Darell D. Bigner, MD, PhD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00002753     History of Changes
Other Study ID Numbers: CDR0000064689, DUMC-1965-98-12R7, DUMC-1752-96-12R5, DUMC-1775-95-12R4, DUMC-1860-97-12R6, NCI-H96-0008
Study First Received: November 1, 1999
Last Updated: February 15, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
childhood supratentorial ependymoma
recurrent childhood brain tumor
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult myxopapillary ependymoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult ependymoblastoma
recurrent childhood cerebral astrocytoma
recurrent childhood ependymoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014