Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
This study has been completed.
Sponsor:
Peregrine Pharmaceuticals
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00677716
First received: May 12, 2008
Last updated: February 2, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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: | February 2, 2012 |
| 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 June 17, 2013