Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

Study Overview
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Brief Summary
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RATIONALE: 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. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

Detailed Description
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OBJECTIVES: Primary To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM To characterize the biodistribution and radiation dosimetry of Cotara® OUTLINE: This is an open-label, dose escalation study of Cotara®. All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.

Official Title
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Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme

Conditions
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Recurrent Glioblastoma Multiforme

Intervention / Treatment
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* Drug: 131-I-chTNT-1/B MAB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrent GBM Patients with a Clinical Target Volume between 5 and 60 cc (inclusive) Patients of 18 years of age or older Karnofsky Performance Status ≥ 60 at screening Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry Exclusion Criteria: Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm Patients with diffuse disease Patients with known or suspected allergy to study medication or iodine Patients who received investigational agents within 30 days prior to baseline Patients who received surgical resection within 4 weeks from baseline Patients with known HIV or evidence of active hepatitis Patients who cannot undergo MRI

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1.5 mCi/cc | Drug: 131-I-chTNT-1/B MAB<br>* The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.<br>* Other names: Cotara;|
| Experimental: 2<br>2.0 mCi/cc | Drug: 131-I-chTNT-1/B MAB<br>* The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.<br>* Other names: Cotara;|
| Experimental: 3<br>2.5 mCi/cc | Drug: 131-I-chTNT-1/B MAB<br>* The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.<br>* Other names: Cotara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To confirm dose limit and maximum tolerated dose and to characterize radiation distribution |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain cancer, Cotara, radioactive isotope, monoclonal antibody, radiation distribution