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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

Primary Purpose

Brain and Central Nervous System Tumors, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iodine I 131 monoclonal antibody 81C6
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, newly diagnosed childhood ependymoma, recurrent childhood ependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven primary or metastatic malignant supratentorial anaplastic glioma Newly diagnosed or recurrent No diffusely infiltrating or multifocal tumor No tumor with subependymal spread Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study Measurable lesion on enhanced CT scan or MRI No measurable enhancing lesion greater than 1.0 cm beyond cavity margin 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/mm^3 Platelet count greater than 100,000/mm^3 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: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior 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: At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Surgery: See Disease Characteristics

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 15, 2014
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00002752
Brief Title
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
Official Title
PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 1993 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.
Detailed Description
OBJECTIVES: Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas. Determine the objective therapeutic response of these patients treated with this regimen. OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs no). Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly. Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Metastatic Cancer
Keywords
childhood supratentorial ependymoma, recurrent childhood brain tumor, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pilocytic astrocytoma, adult subependymoma, adult ependymoblastoma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, newly diagnosed childhood ependymoma, recurrent childhood ependymoma, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
iodine I 131 monoclonal antibody 81C6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven primary or metastatic malignant supratentorial anaplastic glioma Newly diagnosed or recurrent No diffusely infiltrating or multifocal tumor No tumor with subependymal spread Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study Measurable lesion on enhanced CT scan or MRI No measurable enhancing lesion greater than 1.0 cm beyond cavity margin 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/mm^3 Platelet count greater than 100,000/mm^3 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: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior 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: At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darell D. Bigner, MD, PhD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers

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