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Sponsored by: |
Peregrine Pharmaceuticals |
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Information provided by: | Peregrine Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00677716 |
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 |
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Glioblastoma Multiforme |
Drug: 131I-chTNT-1/B MAb (Cotara) |
Phase II |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dianne Uphoff, RN | 714-508-6031 | duphoff@peregrineinc.com |
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 |
Principal Investigator: | Deepak K Gupta, MBBS, MS, MCh | All India Institute of Medical Sciences, New Delhi |
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 |
glioblastoma multiforme GBM brain cancer Cotara |
radioactive isotope monoclonal antibody Glioblastoma multiforme at first relapse |
Glioblastoma Astrocytoma Recurrence Antibodies, Monoclonal Brain Neoplasms Neuroectodermal Tumors Antibodies |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Glioblastoma Multiforme Neoplasms, Glandular and Epithelial Immunoglobulins |
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 |