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Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
This study is currently recruiting participants.
Verified by Peregrine Pharmaceuticals, March 2009
First Received: May 12, 2008   Last Updated: March 18, 2009   History of Changes
Sponsored by: Peregrine Pharmaceuticals
Information provided by: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00677716
  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 II

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 40
Study Start Date: July 2007
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677716

Contacts
Contact: Dianne Uphoff, RN 714-508-6031 duphoff@peregrineinc.com

Locations
India
All India Institute of Medical Sciences Recruiting
New Delhi, India, 110029
Contact: Deepak K Gupta, MBBS, MS, MCh         dkg_nsurgery@yahoo.co.in    
Sub-Investigator: Deepak K Gupta, MBBS, MS, MCh            
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 ( Dianne Uphoff )
Study ID Numbers: PPHM 0503
Study First Received: May 12, 2008
Last Updated: March 18, 2009
ClinicalTrials.gov Identifier: NCT00677716     History of Changes
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

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Recurrence
Antibodies, Monoclonal
Brain Neoplasms
Neuroectodermal Tumors
Antibodies
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Glioblastoma Multiforme
Neoplasms, Glandular and Epithelial
Immunoglobulins

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

ClinicalTrials.gov processed this record on May 07, 2009