NCT00003484

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 1997

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 30, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

April 22, 2015

Conditions

Brain and Central Nervous System TumorsNeuroblastoma

Keywords

localized resectable neuroblastomarecurrent adult brain tumoradult craniopharyngiomaadult medulloblastomaadult meningiomaadult glioblastomaadult oligodendrogliomaadult anaplastic astrocytomaadult mixed gliomaadult pineal parenchymal tumoradult central nervous system germ cell tumoradult grade III meningiomaadult pilocytic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

carmustineDRUG
irinotecan hydrochlorideDRUG
surgical procedurePROCEDURE
iodine I 131 monoclonal antibody 81C6RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor * No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or multifocal tumors * Candidate for surgical resection * Prior external beam radiotherapy to site of measurable disease or resection site in the nervous system required * Presence of tenascin in the tumor demonstrated by immunohistology with either a polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Alkaline phosphatase less than 1.5 times normal * Lactic dehydrogenase less than 1.5 times normal * SGOT less than 1.5 times normal Renal: * Creatinine less than 1.2 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No iodine allergies PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days Radiotherapy: * See Disease Characteristics 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 NeoplasmsNeuroblastomaBrain NeoplasmsCraniopharyngiomaMedulloblastomaMeningiomaGlioblastomaOligodendrogliomaAstrocytomaGliomaPinealomaGliosarcoma

Interventions

CarmustineIrinotecanSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System DiseasesNeoplasms, Vascular TissueMeningeal Neoplasms

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Darell D. Bigner, MD, PhD

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, The Preston Robert Tisch Brain Tumor Center at Duke

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 30, 2003

Study Start

September 1, 1997

Primary Completion

November 1, 2003

Study Completion

March 1, 2010

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

US(1)