Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse

April 23, 2014 updated by: Peregrine Pharmaceuticals

Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.

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

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560 017
        • Manipal Institute for Neurological Disorders,
      • Mumbai, India
        • Department of Neurosurgery Jaslok Hospital and Research Centre
      • New Delhi, India, 110029
        • All India Instutite of Medical Sciences
    • Kerala
      • Cochin, Kerala, India, 682026
        • Amrita Institute of Medical Sciences and Research Center,
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Department of Neurosurgery
    • South Carolina
      • Charleston,, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed GBM
  • Clinical Target Volume between 5 and 60 cc (inclusive)
  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 131I-chTNT-1/B MAb (Cotara)
Drug: 131I-chTNT-1/B MAb (Cotara)
Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.
Other Names:
  • Cotara®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To confirm the safety and tolerability of the maximum tolerated dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peregrine Pharmaceuticals

Investigators

  • Principal Investigator: Deepak K Gupta, MBBS,MS,MCh, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 13, 2008

First Posted (Estimate)

May 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPHM 0503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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