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Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

NCT00509301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-08-05

No results posted yet for this study

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.

Conditions

  • Recurrent Glioblastoma Multiforme

Interventions

DRUG

131-I-chTNT-1/B MAB

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

Sponsors & Collaborators

  • Peregrine Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sunil J Patel, MD · Medical University of South Carolina

  • Kenneth M Spicer, MD PhD · Medical University of South Carolina

  • Kevin D Judy, MD · University of Pennsylvania

  • William R Shapiro, MD · Barrow Neurological Institute

  • Andrew E Sloan, MD, FACS · University Hospitals Cleveland Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00509301 on ClinicalTrials.gov