NCT00004017

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors. PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2000

Completed
3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

March 1, 2003

First QC Date

November 1, 1999

Last Update Submit

February 6, 2009

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumoradult glioblastomaadult anaplastic astrocytomaadult giant cell glioblastomaadult gliosarcoma

Interventions

conventional surgeryPROCEDURE
iodine I 131 monoclonal antibody TNT-1/BRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA) * MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm\^3 * Recurrent GBM and AA must be documented by MRI after the most recent treatment and before any planned surgical debulking * At least 5 days since prior surgical debulking * No planned resection of newly diagnosed GBM before or during study * No bilateral noncontiguous gadolinium enhancing tumors * No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip * No more than 2 satellite lesions PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 Hepatic: * Hepatitis B surface antigen negative * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN * Lactic dehydrogenase no greater than 3 times ULN * Prothrombin time no greater than 1.5 times ULN Renal: * Creatinine clearance at least 50 mL/min Cardiovascular: * No significant unstable cardiovascular disease * No New York Heart Association class III/IV heart disease * No evidence of myocardial infarction within the past 3 months Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Human antichimeric antibody (HACA) titer no greater than 48 ng/mL * No anatomical or physiological considerations that would preclude study participation * No active autoimmune disease, active infection, or traumatic injury requiring treatment * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers Endocrine therapy: * Not specified Radiotherapy: * At least 8 weeks since prior external beam or gamma knife radiotherapy Surgery: * See Disease Characteristics Other: * At least 30 days since prior investigational treatment

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

Sponsors & Collaborators

Study Sites (4)

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28207-1830, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGlioblastomaAstrocytomaGliosarcoma

Interventions

131I-chimeric TNT-1-B monoclonal antibody

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Terrence G. Chew, MD

    Peregrine Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

February 1, 2000

Last Updated

February 9, 2009

Record last verified: 2003-03

Locations

US(4)