NCT00002752

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 1993

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1993

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 8, 2003

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 16, 2014

Status Verified

February 1, 2013

Enrollment Period

9.9 years

First QC Date

November 1, 1999

Last Update Submit

July 15, 2014

Conditions

Brain and Central Nervous System TumorsMetastatic Cancer

Keywords

childhood supratentorial ependymomarecurrent childhood brain tumorrecurrent adult brain tumoradult medulloblastomaadult glioblastomatumors metastatic to brainchildhood high-grade cerebral astrocytomaadult anaplastic astrocytomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomaadult pilocytic astrocytomaadult subependymomaadult ependymoblastomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood medulloblastomanewly diagnosed childhood ependymomarecurrent childhood ependymomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

iodine I 131 monoclonal antibody 81C6RADIATION

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsNeoplasm MetastasisBrain NeoplasmsMedulloblastomaGlioblastomaAstrocytomaEpendymomaOligodendrogliomaGliomaGlioma, SubependymalNeuroectodermal Tumors, PrimitiveFamilial ependymomaGliosarcoma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Darell D. Bigner, MD, PhD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 8, 2003

Study Start

February 1, 1993

Primary Completion

January 1, 2003

Study Completion

March 1, 2010

Last Updated

July 16, 2014

Record last verified: 2013-02

Locations

US(1)