NCT00677716

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

Geographic Reach
2 countries

7 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

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

4.2 years

First QC Date

May 12, 2008

Last Update Submit

April 23, 2014

Conditions

Glioblastoma Multiforme

Keywords

glioblastoma multiformeGBMbrain cancerCotararadioactive isotopemonoclonal antibodyGlioblastoma multiforme at first relapse

Outcome Measures

Primary Outcomes (1)

  • To confirm the safety and tolerability of the maximum tolerated dose

Secondary Outcomes (1)

  • To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Study Arms (1)

131I-chTNT-1/B MAb (Cotara)

EXPERIMENTAL
Drug: 131I-chTNT-1/B MAb (Cotara)

Interventions

131I-chTNT-1/B MAb (Cotara)DRUG

Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.

Also known as: Cotara®
131I-chTNT-1/B MAb (Cotara)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed GBM
  • Clinical Target Volume between 5 and 60 cc (inclusive)
  • to 75 years old (inclusive)
  • Karnofsky Performance Status ≥ 70 percent
  • If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
  • Adequate hematology
  • Adequate renal function
  • Adequate liver function

You may not qualify if:

  • Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
  • Bilateral non-contiguous gadolinium enhancing tumor
  • Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
  • Known or suspected allergy to study medication or iodine
  • Surgical procedure within four weeks of baseline
  • More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline
  • Radiation therapy within four weeks of baseline
  • Investigational agent within last 30 days
  • Previous treatment with any chimeric monoclonal antibody
  • HIV positive
  • Evidence of active hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

University of Pennsylvania, Department of Neurosurgery

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Amrita Institute of Medical Sciences and Research Center,

Kochi, Kerala, 682026, India

Location

Manipal Institute for Neurological Disorders,

Bangalore, 560 017, India

Location

Department of Neurosurgery Jaslok Hospital and Research Centre

Mumbai, India

Location

All India Instutite of Medical Sciences

New Delhi, 110029, India

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

  • Deepak K Gupta, MBBS,MS,MCh

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

US(3)IN(4)