Status:
COMPLETED
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
Lead Sponsor:
Peregrine Pharmaceuticals
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00677716
Start Date
July 1 2007
End Date
November 1 2011
Last Update
April 24 2014
Active Locations (7)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
University of Pennsylvania, Department of Neurosurgery
Philadelphia, Pennsylvania, United States, 19104
3
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
Amrita Institute of Medical Sciences and Research Center,
Kochi, Kerala, India, 682026