Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
Completed · Phase 2
Conditions studied: Glioblastoma Multiforme
In brief
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.
Key facts
- Study ID
- NCT00677716
- Run by
- Peregrine Pharmaceuticals
- People needed
- 41
- Starts
- 2007-07-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2014-04-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- University of Pennsylvania, Department of Neurosurgery — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Amrita Institute of Medical Sciences and Research Center, — Kochi, Kerala, India
- Manipal Institute for Neurological Disorders, — Bangalore, India
- Department of Neurosurgery Jaslok Hospital and Research Centre — Mumbai, India
- All India Instutite of Medical Sciences — New Delhi, India
Full record on ClinicalTrials.gov
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