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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00677716
First received: May 12, 2008
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment. [ Time Frame: Unknown ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00677716     History of Changes
Other Study ID Numbers: PPHM 0503
Study First Received: May 12, 2008
Last Updated: April 23, 2014
Health Authority: India: Drugs Controller General of India

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
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 28, 2014