Expired Study
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Charleston,, South Carolina 29425


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.


Study summary:

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.


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


NCT ID:

NCT00677716


Primary Contact:

Principal Investigator
Deepak K Gupta, MBBS,MS,MCh
All India Institute of Medical Sciences, New Delhi


Backup Contact:

N/A


Location Contact:

Charleston,, South Carolina 29425
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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