NCT00509301

Brief Summary

RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

3.3 years

First QC Date

July 27, 2007

Last Update Submit

August 3, 2011

Conditions

Recurrent Glioblastoma Multiforme

Keywords

brain cancerCotararadioactive isotopemonoclonal antibodyradiation distribution

Outcome Measures

Primary Outcomes (1)

  • To confirm dose limit and maximum tolerated dose and to characterize radiation distribution

Study Arms (3)

1

EXPERIMENTAL

1.5 mCi/cc

Drug: 131-I-chTNT-1/B MAB

2

EXPERIMENTAL

2.0 mCi/cc

Drug: 131-I-chTNT-1/B MAB

3

EXPERIMENTAL

2.5 mCi/cc

Drug: 131-I-chTNT-1/B MAB

Interventions

131-I-chTNT-1/B MABDRUG

The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

Also known as: Cotara
123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with recurrent GBM
  • Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
  • Patients of 18 years of age or older
  • Karnofsky Performance Status ≥ 60 at screening
  • Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry

You may not qualify if:

  • Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
  • Patients with diffuse disease
  • Patients with known or suspected allergy to study medication or iodine
  • Patients who received investigational agents within 30 days prior to baseline
  • Patients who received surgical resection within 4 weeks from baseline
  • Patients with known HIV or evidence of active hepatitis
  • Patients who cannot undergo MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Interventions

131I-chimeric TNT-1-B monoclonal antibody

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sunil J Patel, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Kenneth M Spicer, MD PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Kevin D Judy, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • William R Shapiro, MD

    Barrow Neurological Institute

    PRINCIPAL INVESTIGATOR

  • Andrew E Sloan, MD, FACS

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 31, 2007

Study Start

November 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

US(4)