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.
Full Title of Study: “Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2011
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.
- 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.
Arms, Groups and Cohorts
- Experimental: 131I-chTNT-1/B MAb (Cotara)
Clinical Trial Outcome Measures
- To confirm the safety and tolerability of the maximum tolerated dose
- To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Peregrine Pharmaceuticals
- Provider of Information About this Clinical Study
- Overall Official(s)
- Deepak K Gupta, MBBS,MS,MCh, Principal Investigator, All India Institute of Medical Sciences, New Delhi
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