Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 131I-chTNT-1/B MAb (Cotara) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 131I-chTNT-1/B MAb (Cotara) | Drug | Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To confirm the safety and tolerability of the maximum tolerated dose |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deepak K Gupta, MBBS,MS,MCh | All India Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| University of Pennsylvania, Department of Neurosurgery |
Not provided
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
Not provided
Not provided
| ID | Term |
|---|---|
| C576180 | 131I-chimeric TNT-1-B monoclonal antibody |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Amrita Institute of Medical Sciences and Research Center, | Kochi | Kerala | 682026 | India |
| Manipal Institute for Neurological Disorders, | Bangalore | 560 017 | India |
| Department of Neurosurgery Jaslok Hospital and Research Centre | Mumbai | India |
| All India Instutite of Medical Sciences | New Delhi | 110029 | India |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |