We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00677716
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : April 24, 2014
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

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.

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

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  (Clinical Trial)
Actual Enrollment : 41 participants
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
Study Start Date : July 2007
Primary Completion Date : September 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Cotara®



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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677716


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

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00677716     History of Changes
Other Study ID Numbers: PPHM 0503
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: April 24, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Glioblastoma
Recurrence
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes