Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse

Study Overview
=================
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 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.

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.

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

Conditions
-----------------
Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: 131I-chTNT-1/B MAb (Cotara)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 131I-chTNT-1/B MAb (Cotara)<br> | Drug: 131I-chTNT-1/B MAb (Cotara)<br>* Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.<br>* Other names: Cotara®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm the safety and tolerability of the maximum tolerated dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBM, glioblastoma multiforme, brain cancer, Cotara, radioactive isotope, monoclonal antibody, Glioblastoma multiforme at first relapse