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

This study has been completed.
Information provided by (Responsible Party):
Peregrine Pharmaceuticals Identifier:
First received: May 12, 2008
Last updated: April 23, 2014
Last verified: April 2014
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.

Condition Intervention Phase
Glioblastoma Multiforme Drug: 131I-chTNT-1/B MAb (Cotara) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse

Resource links provided by NLM:

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:
  • To confirm the safety and tolerability of the maximum tolerated dose

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

Enrollment: 41
Study Start Date: July 2007
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cotara®

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00677716

United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, Pennsylvania
University of Pennsylvania, Department of Neurosurgery
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston,, South Carolina, United States, 29425
Amrita Institute of Medical Sciences and Research Center,
Cochin, Kerala, India, 682026
Manipal Institute for Neurological Disorders,
Bangalore, India, 560 017
Department of Neurosurgery Jaslok Hospital and Research Centre
Mumbai, India
All India Instutite of Medical Sciences
New Delhi, India, 110029
Sponsors and Collaborators
Peregrine Pharmaceuticals
Principal Investigator: Deepak K Gupta, MBBS,MS,MCh All India Institute of Medical Sciences, New Delhi
  More Information

Responsible Party: Peregrine Pharmaceuticals Identifier: NCT00677716     History of Changes
Other Study ID Numbers: PPHM 0503
Study First Received: May 12, 2008
Last Updated: April 23, 2014

Keywords provided by Peregrine Pharmaceuticals:
glioblastoma multiforme
brain cancer
radioactive isotope
monoclonal antibody
Glioblastoma multiforme at first relapse

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes processed this record on August 18, 2017